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

Lubricant, Patient

21 CFR 880.6375 / General Hospital
FDA source (opens on fda.gov)

KMJ is the FDA product code for Lubricant, Patient, a class I device type, regulated under 21 CFR 880.6375. As of , FDA records hold 49 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
KMJ
Device name
Lubricant, Patient
Regulation
21 CFR 880.6375
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
49
Ingested recalls
17

Clearances, product code KMJ

By decision year
49 clearances under product code KMJ with a decision year between 1977 and 2015, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KMJ by decision year
YearClearances
19771
19793
19813
19822
19853
19861
19873
19882
19892
19903
19912
19931
19941
19953
19962
19971
19981
20031
20041
20051
20083
20091
20101
20111
20123
20131
20141
20151

Applicants with the most clearances

Product code KMJ
Applicants holding the most 510(k) clearances under product code KMJ
ApplicantClearances
Span-America Medical Systems, Inc.3
Abco Dealers, Inc.2
Biofilm, Inc.2
General Medical Co.2
Osbon Medical Systems, Ltd.2
Pediatric Pharmaceuticals, Inc.2
A.D.T. Lab Industries1
American Medical Systems, Inc.1
Avail Medical Products, Inc.1
Chester Labs, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 104 companies shown, in name order