# K961355: Multicheck

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Jun 14, 1996 after 67 days
- Product code: JJS (Controls For Blood-Gases, (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K952725 (1996). 1 ancestor in all.
36 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952725: Multicheck, Radiometer America, Inc. (1996) Summary page 1.

## Most influential descendants
- K980135: QUALICHECK5+ Models S7730, S7740, S7750, S7760 (1998), 35 descendants of its own
- K992859: ABL700 Series Analyzer with Autocheck Module (2000), 31 descendants of its own
- K041874: ABL800 Flex (2004), 29 descendants of its own
- K050869: Modification to ABL800 Flex (2005), 18 descendants of its own
- K092686: ABL90 Flex Series (2010), 12 descendants of its own

## Indications for use
Multicheck™ with metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Oximetry, Electrolytes, and Glucose and Lactate.

Source page: https://510kreport.com/device/K961355
Methodology: https://510kreport.com/methodology