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

Cushion, Flotation

21 CFR 890.3175 / Physical Medicine
FDA source (opens on fda.gov)

KIC is the FDA product code for Cushion, Flotation, a class I device type, regulated under 21 CFR 890.3175. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KIC
Device name
Cushion, Flotation
Regulation
21 CFR 890.3175
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
29
Ingested recalls
1

Clearances, product code KIC

By decision year
29 clearances under product code KIC with a decision year between 1976 and 1996, 1981 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KIC by decision year
YearClearances
19761
19781
19801
19814
19821
19834
19843
19852
19864
19871
19911
19941
19954
19961

Applicants with the most clearances

Product code KIC
Applicants holding the most 510(k) clearances under product code KIC
ApplicantClearances
D.A. Schulman, Inc.2
Jay Medical, Ltd.2
Maddak, Inc.2
Medical Industries America, Inc.2
Span-America Medical Systems, Inc.2
Steridyne Corp.2
American Pharmaseal Div. Ahsc1
Conphar, Inc.1
Dignicare1
Duro-Med Ind., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 128 companies shown, in name order