510(k) Report

FDA product code · Anesthesiology

Device For Sleep Apnea Testing Based On Mandibular Movement

QRSClass II21 CFR 868.2376510(k) required3 decisions since 20220 recalls

3 FDA decisions since 2022. 510(k) reviews decided 2021–2025 took a median of 153 days (half between 150 and 155). No recall names this code. The most-cited predicate is K222262, named by 1 later device.

A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, anesthesiology panel

Twenty years of QRS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QRS

1in 2025

2022: 22025: 1
2007high 2 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QRS

Too few QRS 510(k)s in any year since 2007 to give a median.

Recalls per year · QRS

No recall names QRS since 2007.

Adverse event reports per year · QRS

No MAUDE report names QRS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20222—00
20230—00
20240—00
20251—00
20260—0—
FIG. 1 — QRS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QRS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do QRS devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K222262SunriseSunrise SA · 20221cites it
  • DEN210015Sunrise Sleep Disorder Diagnostic AidSunrise · 20221cites it

Which QRS devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K250874SunriseSunrise SA · 20252generations
  • K222262SunriseSunrise SA · 20221generation

What has FDA decided in QRS lately?

  • K250874SunriseSunrise SA · 2025
  • K222262SunriseSunrise SA · 2022
  • DEN210015Sunrise Sleep Disorder Diagnostic AidSunrise · 2022

All 3 QRS decisions →