# K962158: Pico Models 30, 50, 70

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Oct 29, 1996 after 147 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 K896514 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896514: QS90 Smooth E Arterial Blood Sampler, Radiometer America, Inc. (1990) Summary page 1.

## Most influential descendants
- K043143: Safepico (2005), 0 descendants of its own

## Recalls of this device
- Apr 8, 2022 · Class II · Z-1115-2022: Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.

## Indications for use
Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses.

Source page: https://510kreport.com/device/K962158
Methodology: https://510kreport.com/methodology