510(k) Report

FDA product code · Hematology

Manual Blood Grouping And Antibody Test Systems

PBCClass II21 CFR 864.9175510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.

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 PBC 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 · PBC

FDA has decided no PBC device since 2007.

Median 510(k) review, days · PBC

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

Recalls per year · PBC

No recall names PBC since 2007.

Adverse event reports per year · PBC

1in 2024

2016: 12024: 1
2007high 1 (2016) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—
FIG. 1 — PBC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PBC? 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 864.9175.

OQX Self-Contained Blood GroupingKSZ System, Test, Automated Blood Grouping And…