FDA product code · General and plastic surgery

Vacuum Powered Body Fluid Collection Kit

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

OJRClass II21 CFR 878.47800 decisions0 recalls

0 FDA decisions. No recall names this code.

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, general and plastic surgery panel

Twenty years of OJR 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 · OJR

FDA has decided no OJR device since 2007.

Median 510(k) review, days · OJR

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

Recalls per year · OJR

No recall names OJR since 2007.

Adverse event reports per year · OJR

17in 2022

2007high 17 (2022) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	17
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in OJR? 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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