FDA product code · Hematology

Warmer, Blood, Electromagnetic Radiation

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

BSAClass III21 CFR 864.9205PMA required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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, hematology panel

Twenty years of BSA 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 · BSA

FDA has decided no BSA device since 2007.

Median 510(k) review, days · BSA

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

Recalls per year · BSA

No recall names BSA since 2007.

Adverse event reports per year · BSA

1in 2022

2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code BSA, 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	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in BSA? 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 864.9205.

KZL Device, Warming. Blood And Plasma BSB Warmer, Blood, Non-Electromagnetic Radiation