# K981035: Pro-Vent, Pulsator Arterial Blood Sampling Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Sims Portex, Inc.
- Decided: Apr 21, 1998 after 33 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952516 (1995). 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)
- K952516: Pro-Vent, Line Draw, Pulsator, Smiths Industries Medical Systems, Inc. (1995) Summary page 1.

## Recalls of this device
- Jul 13, 2018 · Class III · Z-3196-2018: The product was mislabeled with the incorrect label.

## Indications for use
The arterial blood sampling syringe is intended for sampling of arterial blood for the measurement of pOo, pCO», pH, CO-oximetry, electrolytes (Ca**, Na*, K*, CI-, and Mg+t), Total Magnesium, and the metabolites (Glucose and Lactate).

Source page: https://510kreport.com/device/K981035
Methodology: https://510kreport.com/methodology