FDA product code KMJ: Lubricant, Patient
KMJ is the FDA product code for lubricant, patient. It is a Class I device, regulated under 21 CFR 880.6375 and reviewed by the General Hospital panel. FDA has cleared 49 510(k) submissions under KMJ, from 42 different applicants. The average 510(k) review took 101 days (median 86). FDA has posted 17 recalls for KMJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lubricant, Patient |
| Device class | Class I |
| Regulation | 21 CFR 880.6375 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KMJ clearance
Top KMJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Span-America Medical Systems, Inc. | 3 | 1996-07-18 |
| Pediatric Pharmaceuticals, Inc. | 2 | 2014-07-24 |
| Biofilm, Inc. | 2 | 2003-01-24 |
| General Medical Co. | 2 | 1991-09-27 |
| Osbon Medical Systems, Ltd. | 2 | 1989-12-01 |
37 more applicants have KMJ clearances. See the full list in Caduvo.
Most recent KMJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142473 | Sion Biotext Medical , Ltd. | Lubricating Jelly | 2015-04-13 | 222 |
| K141028 | Pediatric Pharmaceuticals, Inc. | COLONGLIDE LUBRICANT | 2014-07-24 | 93 |
| K131617 | Pediatric Pharmaceuticals, Inc. | COLONGLIDE(R) LUBRICANT | 2013-10-03 | 122 |
| K121390 | Nurse Assist, Inc. | LUBE JELLY SURINGE | 2012-08-10 | 93 |
| K113689 | Dukal Corporation | DUKAL LUBRICATING JELLY | 2012-05-04 | 141 |
Recalls for KMJ devices
17 product recalls in 10 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code KMJ?
KMJ is the FDA product code for lubricant, patient. It is a Class I device, regulated under 21 CFR 880.6375 and reviewed by the General Hospital panel.
What device class is KMJ?
Class I, regulation 21 CFR 880.6375. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KMJ?
Across 49 cleared submissions the average was 101 days from receipt to decision (median 86).
Which companies have the most KMJ clearances?
Span-America Medical Systems, Inc. (3); Pediatric Pharmaceuticals, Inc. (2); Biofilm, Inc. (2); General Medical Co. (2); Osbon Medical Systems, Ltd. (2).
Have KMJ devices been recalled?
Yes: 17 product recalls across 10 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code KMJ
- Run a recall and safety report across every KMJ manufacturer
- Watch product code KMJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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