# JJS: Controls For Blood-Gases, (Assayed And Unassayed)

- Device class: 1; regulation: 21 CFR 862.1660; FDA's rule: 510(k) exempt
- FDA decisions: 67
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1995: 6
- 1996: 3
- 1997: 1
- 1998: 1
- 2000: 7
- 2002: 2
- 2003: 1
- 2013: 2
- 2015: 1
- 2016: 1

## Most-cited predicates
- K980135: QUALICHECK5+ Models S7730, S7740, S7750, S7760 (1998), cited by 6
- K002536: Liquichek Blood Gas Plus CO-Oximeter Control, Models 637, 638, 639 (Radiometer) (2000), cited by 1
- K961355: Multicheck (1996), cited by 1
- K003242: Liquichek Blood Gas Plus CO-Oximeter Control (IL), Model 621,622,623 (2000), cited by 1
- K950902: Alko Tonometered Saline Control (1995), cited by 1
- K952637: Qualicheck 4 Glucose (1995), cited by 1

Source page: https://510kreport.com/product-code/JJS
Data by year (CSV): https://510kreport.com/product-code/JJS.csv