# K955663: Abc in-Line Blood Sampling Kit

- Pathway: 510(k) (Traditional)
- Applicant: Utah Medical Products, Inc.
- Decided: Mar 17, 1997 after 460 days
- Product code: CBT (Arterial Blood Sampling Kit)
- Device class: 1
- Regulation: 21 CFR 868.1100
- 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 K885281 (1989). 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)
- K885281: Vamp Venous/Arterial Blood Management Protection, Baxter Healthcare Corp (1989) Summary page 1.

## Indications for use
The ABC (“Arterial Blood Collection) In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.

Source page: https://510kreport.com/device/K955663
Methodology: https://510kreport.com/methodology