510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KMOClass I

Binder, Elastic

21 CFR 880.5160 / General Hospital
FDA source (opens on fda.gov)

KMO is the FDA product code for Binder, Elastic, a class I device type, regulated under 21 CFR 880.5160. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KMO
Device name
Binder, Elastic
Regulation
21 CFR 880.5160
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code KMO

By decision year
5 clearances under product code KMO with a decision year between 1980 and 1993, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KMO by decision year
YearClearances
19801
19881
19892
19931

Applicants with the most clearances

Product code KMO
Applicants holding the most 510(k) clearances under product code KMO
ApplicantClearances
Boston Pacific Medical, Inc.1
Custom Hospitals Products1
General Cardiac Technology, Inc.1
Procter & Gamble Mfg. Co.1
Storer Medical Products1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 39 companies shown, in name order