KRBClass II

Probe, Thermodilution

21 CFR 870.1915 / Cardiovascular

KRB is the FDA product code for Probe, Thermodilution, a class II device type, regulated under 21 CFR 870.1915. As of 2026-09-10, FDA records hold 37 510(k) clearances under this code, the most recent dated 2018-02-21, and 4 recalls.

Classification record

Product code: KRB
Device name: Probe, Thermodilution
Regulation: 21 CFR 870.1915
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 37
Ingested recalls: 4

Clearances, product code KRB

By decision year

37 clearances under product code KRB with a decision year between 1976 and 2018, 1981 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code KRB by decision year
Year	Clearances
1976	3
1977	1
1979	2
1980	3
1981	6
1982	1
1983	1
1984	4
1987	1
1988	3
1989	1
1990	2
1991	2
1992	1
1994	1
2000	1
2002	1
2007	1
2010	1
2018	1

Applicants with the most clearances

Product code KRB

Applicants holding the most 510(k) clearances under product code KRB
Applicant	Clearances
Gould, Inc.	3
Instrumentation Laboratory Co.	3
Pulsion Medical Systems AG	3
American Edwards Laboratories	2
Andover Medical, Inc.	2
Edwards Laboratories	2
Abbott Medical	1
Ackrad Laboratories	1
American Pharmaseal Div. Ahsc	1
Bentley Laboratories, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order