# K830014: Hema - NV Trans. Blood Filter 100/800

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 17, 1983 after 14 days
- Product code: CAK (Microfilter, Blood Transfusion)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 20, 2006 · Not classified · Z-0542-2007: The tubing can separate from the set at the filter inlet post.
- Jan 9, 2006 · Not classified · Z-0504-06: 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: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Sep 29, 2005 · Not classified · Z-0134-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Sep 29, 2005 · Not classified · Z-0135-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- May 6, 2005 · Not classified · Z-0195-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.

Source page: https://510kreport.com/device/K830014
Methodology: https://510kreport.com/methodology