FDA product code KME: Bedding, Disposable, Medical
KME is the FDA product code for bedding, disposable, medical. It is a Class I device, regulated under 21 CFR 880.6060 and reviewed by the General Hospital panel. FDA has cleared 65 510(k) submissions under KME, from 46 different applicants. The average 510(k) review took 58 days (median 35). FDA has posted 2 recalls for KME devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bedding, Disposable, Medical |
| Device class | Class I |
| Regulation | 21 CFR 880.6060 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KME clearance
Top KME applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sancella, Inc. | 4 | 1991-05-28 |
| Haz-Med, Inc. | 3 | 1991-12-31 |
| Anago, Inc. | 3 | 1990-10-26 |
| Kimberly-Clark Corp. | 3 | 1987-03-13 |
| Procter & Gamble Mfg. Co. | 3 | 1986-07-02 |
41 more applicants have KME clearances. See the full list in Caduvo.
Most recent KME clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042145 | Techtrade, LLC | READY-HEAT BLANKET | 2004-09-17 | 39 |
| K944953 | Thantex Specialties, Inc. | OREX MEDICAL BEDDING | 1994-12-02 | 56 |
| K933636 | Belmac Healthcare Corp. | DISPOSE-A-SHEET | 1994-01-26 | 183 |
| K932539 | Three Dog Down | DOCTOR DOWN --RESCUE WRAP | 1993-11-02 | 160 |
| K922143 | American Silk Sutures, Inc. | AMERICAN BURN SHEET | 1992-08-10 | 96 |
Recalls for KME devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-06-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code KME?
KME is the FDA product code for bedding, disposable, medical. It is a Class I device, regulated under 21 CFR 880.6060 and reviewed by the General Hospital panel.
What device class is KME?
Class I, regulation 21 CFR 880.6060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KME?
Across 65 cleared submissions the average was 58 days from receipt to decision (median 35).
Which companies have the most KME clearances?
Sancella, Inc. (4); Haz-Med, Inc. (3); Anago, Inc. (3); Kimberly-Clark Corp. (3); Procter & Gamble Mfg. Co. (3).
Have KME devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code KME
- Run a recall and safety report across every KME manufacturer
- Watch product code KME 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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