510(k) Report

FDA product code · Cardiovascular

Oximeter, Infrared, Sporting, Aviation

OCHClass II21 CFR 870.27000 decisions0 recalls

0 FDA decisions. No recall names this code.

Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.

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, cardiovascular panel

Twenty years of OCH 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 · OCH

FDA has decided no OCH device since 2007.

Median 510(k) review, days · OCH

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

Recalls per year · OCH

No recall names OCH since 2007.

Adverse event reports per year · OCH

1in 2025

2019: 12021: 12023: 22024: 22025: 1
2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCH, not matched to any one device; reports are not rates.

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—01
20200—00
20210—01
20220—00
20230—02
20240—02
20250—01
20260—0—
FIG. 1 — OCH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OCH? 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

Related product codes

Other codes under 21 CFR 870.2700.

MUD Oximeter, Tissue SaturationPGJ Oximeter, WellnessNLF Oximeter, ReprocessedOLK Pulse Oximeter For Over-The-Counter UseDQA OximeterQEM Cerebral OximeterNMD Oximeter, Tissue Saturation, Reprocessed