510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KRHClass II

Ring, Annuloplasty

21 CFR 870.3800 / Cardiovascular
FDA source (opens on fda.gov)

KRH is the FDA product code for Ring, Annuloplasty, a class II device type, regulated under 21 CFR 870.3800. As of , FDA records hold 75 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KRH
Device name
Ring, Annuloplasty
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
75
Ingested recalls
0

Clearances, product code KRH

By decision year
75 clearances under product code KRH with a decision year between 1979 and 2026, 2009 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code KRH by decision year
YearClearances
19791
19804
19821
19831
19891
19913
19922
19932
19961
19972
19982
19992
20001
20011
20026
20033
20042
20053
20062
20074
20082
20098
20102
20112
20141
20161
20182
20192
20202
20232
20241
20254
20262

Applicants with the most clearances

Product code KRH
Applicants holding the most 510(k) clearances under product code KRH
ApplicantClearances
Genesee BioMedical, Inc.13
Abbott Medical11
Edwards Lifesciences LLC9
Medtronic, Inc.7
Corcym Inc.5
Baxter Healthcare Corporation4
Medtronic Heart Valves3
Sulzer Carbomedics, Inc.3
The Heart Valve Div. Medtronic Cardiovascular Surg3
Shiley, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code