FDA product code · Clinical chemistry

Blood And Urine Collection Kit (Excludes Hiv Testing)

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

OIBClass I21 CFR 864.32500 decisions17 recalls

0 FDA decisions. 17 recalls name this code, 1 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, clinical chemistry panel

Twenty years of OIB 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 · OIB

FDA has decided no OIB device since 2007.

Median 510(k) review, days · OIB

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

Recalls per year · OIB

8in 2023

2007high 8 (2023) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OIB

1in 2024

2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code OIB, 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	—	0	0
2011	—	0	1
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	1
2019	—	2	0
2020	—	0	1
2021	—	0	0
2022	—	0	0
2023	—	8	0
2024	—	0	1
2025	—	0	0
2026	—	7 (1)	—

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

Planning a device in OIB? 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 864.3250.

KDT Container, Specimen Mailer And Storage, Sterile FMH Container, Specimen, Sterile NNI Container, Specimen, Non-Sterile OIE Urine Collection Kit (Excludes Hiv Testing)NNL Container, Specimen Mailer And Storage…OIA Neonatal Blood Collection Kit And Screening…NNK Container, Specimen Mailer And Storage…KDW Container, Specimen Mailer And Storage…OHZ Urine Transport Kit (Excludes Hiv Testing)

Blood And Urine Collection Kit (Excludes Hiv Testing)

What has been recalled in OIB lately?

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