# KMK: Device, Intravascular Catheter Securement

- Device class: 1; regulation: 21 CFR 880.5210; FDA's rule: 510(k) exempt
- FDA decisions: 64
- Recalls: 5 (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)
- 1989: 2
- 1990: 4
- 1991: 6
- 1992: 4
- 1993: 10
- 1994: 7
- 1995: 1
- 1996: 1
- 1999: 1
- 2019: 1

## Most-cited predicates
- K943147: Statlock CV (1994), cited by 2
- K941940: Immobile Sterile and Immobile a/C Sterile (1994), cited by 1
- K895993: Vitapatch Antimicrobial Catheter Securement Device (1990), cited by 1
- K180994: SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F (2019), cited by 1
- K941850: Immobile Non-Sterile and Immobile a/C Non-Sterile (1994), cited by 1

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