510(k) Report

FDA product code · General hospital

Blood Transfusion Kit

POQClass II21 CFR 880.54400 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 hospital panel

Twenty years of POQ 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 · POQ

FDA has decided no POQ device since 2007.

Median 510(k) review, days · POQ

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

Recalls per year · POQ

No recall names POQ since 2007.

Adverse event reports per year · POQ

11in 2021

2021: 11
2007high 11 (2021) · low 0 (2007)2025

MAUDE reports naming product code POQ, 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—00
20170—00
20180—00
20190—00
20200—00
20210—011
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — POQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in POQ? 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 880.5440.