510(k) Report

FDA product code · Anesthesiology

Device Indicating An Exhalation Event

PRKClass II21 CFR 868.2375510(k) required1 decision since 20170 recalls

1 FDA decision since 2017. No recall names this code.

To provide visual indication of each exhalation event

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 PRK 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 · PRK

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PRK

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

Recalls per year · PRK

No recall names PRK since 2007.

Adverse event reports per year · PRK

No MAUDE report names PRK 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
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PRK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PRK? 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 PRK devices have the deepest lineage?

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

  • K161953ReDe MaskTereopneuma · 20172generations

What has FDA decided in PRK lately?

  • K161953ReDe MaskTereopneuma · 2017

The one PRK decision →

Related product codes

Other codes under 21 CFR 868.2375.

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