# K962596: Customed Blood Extraction Kit

- Pathway: 510(k) (Traditional)
- Applicant: Customed, Inc.
- Decided: Sep 27, 1996 after 87 days
- Product code: GJE (Tray, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905464 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905464: Medical Procedure Kits/Arterial Blood Sampling, Angiosystems, Inc. (1991) Summary page 1.

## Indications for use
The Customed Blood Collection Kits are intended to be used by Healthcare professions for venous blood specimen collection and transport, and is for In-Vitro Diagnostic Use only. The kit is used to prepare the skin for sampling, provide blood collection tubes and needles for the sampling procedure, and to cover the sampling site when the procedure is complete.

Source page: https://510kreport.com/device/K962596
Methodology: https://510kreport.com/methodology