FDA product code · Clinical chemistry

Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)

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

OIAClass I21 CFR 864.32500 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, clinical chemistry panel

Twenty years of OIA 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 · OIA

FDA has decided no OIA device since 2007.

Median 510(k) review, days · OIA

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

Recalls per year · OIA

No recall names OIA since 2007.

Adverse event reports per year · OIA

1in 2017

2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code OIA, 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	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in OIA? 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…NNK Container, Specimen Mailer And Storage…OIB Blood And Urine Collection Kit (Excludes Hiv…KDW Container, Specimen Mailer And Storage…OHZ Urine Transport Kit (Excludes Hiv Testing)