FDA product code · General hospital

Microfilter, Blood Transfusion

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

CAKClass II21 CFR 880.5440510(k) required36 decisions since 19760 recalls

36 FDA decisions since 1976. No recall names this code. The most-cited predicate is K811985, named by 1 later device.

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 CAK 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 · CAK

FDA has decided no CAK device since 2007.

Median 510(k) review, days · CAK

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

Recalls per year · CAK

No recall names CAK since 2007.

Adverse event reports per year · CAK

60in 2025

2007high 334 (2019) · low 0 (2012)2025

MAUDE reports naming product code CAK, 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	—	5
2008	—	7
2009	—	8
2010	—	3
2011	—	4
2012	—	0
2013	—	104
2014	—	37
2015	—	58
2016	—	97
2017	—	131
2018	—	58
2019	—	334
2020	—	180
2021	—	18
2022	—	110
2023	—	69
2024	—	19
2025	—	60
2026	—	—

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

Planning a device in CAK? 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.

POQ Blood Transfusion Kit FMG Stopcock, I.V. Set PWQ Buret Administration Intravenous Kit OJA Intravenous Extension Tubing Set FPK Tubing, Fluid Delivery FPA Set, Administration, Intravascular NEP System/Device, Pharmacy Compounding PWH Administrations Sets With Neuraxial Connectors MJF Check Valve, Retrograde Flow (In-Line)PYR Neuraxial Administration Set - Intrathecal…LHI Set, I.V. Fluid Transfer ODI Administration Set Docking Station

Microfilter, Blood Transfusion

Which predicates do CAK devices cite most?

Which CAK devices have the deepest lineage?

What has FDA decided in CAK lately?

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