Hema - NV Trans. Blood Filter 100/800

K830014510(k) TraditionalCleared Jan 17, 198314-day reviewClass II21 CFR 880.5440Recalls 6

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Laboratories · CAK Microfilter, Blood Transfusion

Cleared on Jan 17, 1983 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 6 times.

Decided: Jan 17, 1983
Review: 14 days
Class: Class II
Product code: CAK
Recalls: 6
Predicates: 0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K830014Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 20, 2006	Not classified	Z-0542-2007	Other	The tubing can separate from the set at the filter inlet post.
Jan 9, 2006	Not classified	Z-0504-06	Other	The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.
Sep 29, 2005	Not classified	Z-0133-06	Other	Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
Sep 29, 2005	Not classified	Z-0134-06	Other	Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
Sep 29, 2005	Not classified	Z-0135-06	Other	Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
May 6, 2005	Not classified	Z-0195-06	Other	Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All CAK devices

CAK Microfilter, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—	—

https://510kreport.com/device/K830014 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830014: Hema - NV Trans. Blood Filter 100/800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830014

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026