# K043143: Safepico

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Apr 22, 2005 after 158 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: 2 generations back to K896514 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962158: Pico Models 30, 50, 70, Radiometer America, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K011925: Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle Protectio, Sims Portex, Inc. (2001). Our reading of the summary gave K011925, FDA’s number for Hypodermic Needle-Pro Needle with Needle Protection… (Sims Portex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PRO-VENT with NEEDLE-PRO”. Kept off the family tree. Summary page 1.

## Recalls of this device
- Jul 18, 2006 · Not classified · Z-1443-06: Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.

## Indications for use
The safePICO Arterial Blood Sampler is a preheparinized, electrolyte balanced, arterial blood sampler for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analyses. The safePICO is a vented sampler for sample volumes in the range from 0.7 to 1.5 mL. The safePICO includes a vented tip cap allowing the sampler to be vented after the appliance of the tip cap and may include a needle shield device to prevent a user from accidental needle stick.

Source page: https://510kreport.com/device/K043143
Methodology: https://510kreport.com/methodology