---
title: Submitting 510(k) applications
description: Submitting 510(k) applications
---

[Case Studies Archive - Alacrita ](https://www.alacrita.com/case-studies)

# [Submitting 510(k) applications](https://www.alacrita.com/case-studies/submitting-510k-applications)

 Written by [John Simpson](https://www.alacrita.com/case-studies/author/john-simpson) | Feb 7, 2017 2:34:31 PM

## Challenge

A medical device client needed help securing 510(k) clearance for a non-contact respiratory measurement device.

## Solution

Our 510(k) regulatory affairs consultant provided strategic regulatory guidance and detailed technical input to develop a robust regulatory submission.

Working closely with our client’s in-house technical and regulatory team, we provided expert advice, with the level of detail that the FDA expects. We further developed the submission with expert medical device statistics and with help from software specialists. We accompanied our client to FDA meetings and helped them respond to questions.

Our client was [granted 510(k) marketing clearance](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K151940) in March 2016.

[View full post](https://www.alacrita.com/case-studies/submitting-510k-applications)

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