# KRB: Probe, Thermodilution

- Device class: 2; regulation: 21 CFR 870.1915; FDA's rule: 510(k) required
- FDA decisions: 37
- 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)
- 1989: 1
- 1990: 2
- 1991: 2
- 1992: 1
- 1994: 1
- 2000: 1
- 2002: 1
- 2007: 1
- 2010: 1
- 2018: 1

## Most-cited predicates
- K072364: Pulsion Pulsiocath Thermodilution Catheters & Accessories (2007), cited by 2
- K100739: Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5 (2010), cited by 2
- K830909: Mikro-Tip Cath. Pressure Transducer (1983), cited by 1
- K892941: Cco System Model SP1467,SP5567,SP6267 (1989), cited by 1
- K811411: Swan-Ganz Heparin Coated, Etc. Catheter (1981), cited by 1
- K991886: Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate Sensor (2000), cited by 1

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