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US FDA · Class II, some Class I & III, IVDs

510(k) premarket notification, prepared right the first time

Our FDA 510(k) submission service covers it end to end. We confirm your classification, find the right predicate, build your 510(k) eSTAR submission and handle FDA questions — so your device reaches the US market without avoidable delays.

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90FDA review days (goal)
15days to acceptance review
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The basics

What is an FDA 510(k) submission?

An FDA 510(k) submission is a premarket notification to the US FDA showing your device is substantially equivalent to a legally marketed device (the “predicate”) — as safe and effective, for the same intended use.

It is the route for most medium-risk devices and IVDs that are neither exempt nor require Premarket Approval (PMA). Once FDA clears it, you receive a clearance letter with a unique 510(k) number and can legally sell in the US.

Shorter reviewFDA's goal is 90 review days when the submission is complete and accurate.
Usually no clinical dataMost 510(k)s rely on bench, biocompatibility and performance testing.
Lower FDA fee than PMAReduced fees are available for qualifying small businesses.

Who needs an FDA 510(k) submission?

Required for most Class II devices, some Class I and Class III devices, and many IVDs — by any of these parties:

01
US manufacturersIntroducing a finished device to the US market.
02
Specification developersWho design the device but contract out manufacturing.
03
Re-packagers & re-labellersWhen labelling changes significantly or device condition is affected.
04
Foreign manufacturersAnd exporters selling into the United States.
How it works

The FDA 510(k) submission process, step by step

  1. 1

    Confirm classification

    Week 1

    Confirm the device needs a 510(k) and identify its product code, device class and regulation number from the intended use.

  2. 2

    Select a predicate

    Week 1–2

    Find a legally marketed device equivalent in intended use, materials, technology, operating principle and design.

  3. 3

    Pre-Submission (optional)

    Up to ~70–120 days

    Ask FDA for feedback on testing or predicate choice before you submit. Recommended for novel features.

  4. 4

    Testing & documentation

    Varies

    Generate the performance, safety and equivalence evidence, then compile the submission in eSTAR format.

  5. 5

    Pay the fee & submit

    Day 0

    Pay the FDA user fee and upload the eSTAR. FDA runs a technical screening / acceptance review within about 15 days.

  6. 6

    Substantive review

    90 FDA days (goal)

    FDA evaluates substantial equivalence. An Additional Information request pauses the clock — you have 180 days to respond.

  7. 7

    Clearance

    Done

    FDA issues a clearance letter with your 510(k) number and Indications for Use. You can now market the device in the US.

Submission types

Types of FDA 510(k) submission

FDA accepts three types of 510(k). Picking the right one affects how much data you provide and how fast FDA reviews it.

Traditional 510(k)The standard route for a new device or a significant change. Full comparison to a predicate with supporting performance data. FDA review goal: 90 FDA days.
Special 510(k)For well-defined changes to your own cleared device where design controls and recognized methods can show the change is acceptable. FDA aims to decide within 30 days.
Abbreviated 510(k)Relies on FDA guidance documents, special controls or recognized consensus standards, using summary reports to show conformity instead of full test data.
FDA 510(k) submission process: classification, predicate, testing, eSTAR, FDA review and clearance
The FDA 510(k) submission process at a glance, from classification to clearance.
What FDA expects

What goes into an FDA 510(k) submission?

Since 1 October 2023, every FDA 510(k) submission must be prepared in FDA's electronic eSTAR template. The content depends on your device, but most submissions include:

Device description & indicationsWhat the device is, how it works and its indications for use statement.
Substantial equivalenceSide-by-side comparison with the predicate: intended use, technology and performance.
LabelingLabels, instructions for use and any promotional claims.
BiocompatibilityISO 10993 evaluation and testing for patient-contacting materials.
Software & cybersecuritySoftware documentation per FDA guidance and IEC 62304, plus cybersecurity where relevant.
Electrical safety & EMCIEC 60601-1 and IEC 60601-1-2 testing for powered devices.
Sterilization & shelf lifeSterilization validation, packaging and shelf-life data where applicable.
Performance testingBench, animal or clinical data needed to support equivalence.

Official references: FDA's Premarket Notification 510(k) guidance hub and the FDA 510(k) database for finding predicates.

510(k), De Novo or PMA?

Choosing the wrong pathway is the costliest mistake. Here is how the three compare.

510(k)De NovoPMA
Typical riskModerate (mostly Class II)Low–moderate, novelHigh (Class III)
BasisEquivalence to a predicateNo predicate existsIndependent proof of safety & effectiveness
Clinical dataRarelySometimesAlmost always
FDA review goal90 days150 days180 days
FDA user fee (FY 2027)$28,653
Small business: $7,163		$191,020
Small business: $47,755		$636,732
Small business: $159,183
Our 510(k) service

Our FDA 510(k) submission services

Regulatory strategyClassification, product code and pathway confirmation.
Predicate searchIdentifying and justifying the strongest predicate device.
Testing plan & gap analysisBench, biocompatibility, software (IEC 62304) and usability needs.
Pre-Submission (Q-Sub)Getting FDA feedback before you commit to testing.
eSTAR file preparationComplete, review-ready submission in FDA's required format.
FDA query responsesRTA and Additional Information responses through to clearance.

Related FDA services

FDA Medical Device Classification FDA Medical Device Registration And Listing US FDA Consultants

FDA 510(k) submission FAQs

How long does an FDA 510(k) submission take?

FDA aims to decide within 90 review days. Including preparation, testing and FDA questions, most projects run 6–9 months end to end.

Do I need clinical data for a 510(k)?

Most 510(k)s do not. Bench, biocompatibility, electrical safety, software and usability testing usually demonstrate equivalence. FDA may ask for clinical data when differences from the predicate raise new questions.

What if no suitable predicate exists?

If there is no predicate and the device is low to moderate risk, the De Novo pathway may apply. We assess this during the classification step.

What is eSTAR?

eSTAR is FDA’s electronic submission template. It is mandatory for 510(k) submissions and structures every section FDA expects to see.

Do foreign manufacturers need a US Agent?

Yes. Foreign establishments must name a US Agent when registering with FDA. REGHELPS can act as your US Agent.

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