FDA product code · Gastroenterology and urology

Catheter Care Tray

Name: FDA decisions, review times, recalls and adverse event reports for product code OHR
Creator: 510(k) Report

OHRClass II21 CFR 876.51300 decisions12 recalls

0 FDA decisions. 12 recalls name this code, 0 of them Class I.

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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, gastroenterology and urology panel

Twenty years of OHR 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 · OHR

FDA has decided no OHR device since 2007.

Median 510(k) review, days · OHR

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

Recalls per year · OHR

6so far in 2026, the most since 2007

2007high 6 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OHR

150in 2025

2007high 167 (2022) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	2	0
2011	—	1	0
2012	—	0	0
2013	—	0	0
2014	—	0	1
2015	—	0	11
2016	—	0	25
2017	—	0	25
2018	—	0	34
2019	—	0	63
2020	—	0	22
2021	—	0	48
2022	—	0	167
2023	—	0	144
2024	—	2	162
2025	—	1	150
2026	—	6	—

FIG. 1 — OHR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OHR? 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

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Catheter Care Tray

What has been recalled in OHR lately?

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