# KLK: Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

- Device class: 2; regulation: 21 CFR 868.2500; FDA's rule: 510(k) exempt
- FDA decisions: 47
- Recalls: 3 (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)
- 1985: 3
- 1986: 3
- 1987: 1
- 1989: 1
- 1993: 1
- 1995: 1
- 1996: 1
- 1998: 1
- 1999: 1
- 2001: 1

## Most-cited predicates
- K991644: Microgas 7650 Transcutaneous Monitor (1999), cited by 2
- K925910: Hewlett-Packard Model M1018A TCPO2/TOPCO2 Module (1993), cited by 2
- K003943: Microgas 7650 Transcutaneous Monitor (2001), cited by 2

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