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

Detector, Bubble, Cardiopulmonary Bypass

21 CFR 870.4205 / Cardiovascular
FDA source (opens on fda.gov)

KRL is the FDA product code for Detector, Bubble, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4205. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
KRL
Device name
Detector, Bubble, Cardiopulmonary Bypass
Regulation
21 CFR 870.4205
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
14
Ingested recalls
4

Clearances, product code KRL

By decision year
14 clearances under product code KRL with a decision year between 1980 and 2011, 1993 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KRL by decision year
YearClearances
19801
19841
19861
19871
19911
19932
19942
19962
20071
20091
20111

Applicants with the most clearances

Product code KRL
Applicants holding the most 510(k) clearances under product code KRL
ApplicantClearances
3M Health Care, Sarns2
Cobe Laboratories, Inc.2
Rocky Mountain Research, Inc.2
Sorin Biomedica, Fiat, USA, Inc.2
Delta Medical Industries1
Luna Innovations, Inc.1
Shiley, Inc.1
LivaNova Deutschland GmbH1
Terumo Cardiovascular Systems Corporation1
Terumo Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code