FDA product code KMO: Binder, Elastic
KMO is the FDA product code for binder, elastic. It is a Class I device, regulated under 21 CFR 880.5160 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under KMO, from 5 different applicants. The average 510(k) review took 184 days (median 98).
Classification
| Field | Value |
|---|---|
| Device name | Binder, Elastic |
| Device class | Class I |
| Regulation | 21 CFR 880.5160 |
| 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 KMO clearance
Top KMO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Pacific Medical, Inc. | 1 | 1993-10-08 |
| Custom Hospitals Products | 1 | 1989-08-28 |
| Storer Medical Products | 1 | 1989-01-17 |
| General Cardiac Technology, Inc. | 1 | 1988-09-20 |
| Procter & Gamble Mfg. Co. | 1 | 1980-01-11 |
Most recent KMO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921852 | Boston Pacific Medical, Inc. | 4 SURE TM RECTAL TUBE | 1993-10-08 | 539 |
| K893809 | Custom Hospitals Products | COUGH PILLOW | 1989-08-28 | 98 |
| K883214 | Storer Medical Products | THORACIC SUPPORT SYSTEM | 1989-01-17 | 172 |
| K882592 | General Cardiac Technology, Inc. | HEART HUGGER STERNUM SUPPORT HARNESS | 1988-09-20 | 89 |
| K792629 | Procter & Gamble Mfg. Co. | STERILIZATION PROCESS/T-BINDER | 1980-01-11 | 23 |
Recalls for KMO devices
openFDA lists no recalls for product code KMO.
Frequently asked questions
What is FDA product code KMO?
KMO is the FDA product code for binder, elastic. It is a Class I device, regulated under 21 CFR 880.5160 and reviewed by the General Hospital panel.
What device class is KMO?
Class I, regulation 21 CFR 880.5160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KMO?
Across 5 cleared submissions the average was 184 days from receipt to decision (median 98).
Which companies have the most KMO clearances?
Boston Pacific Medical, Inc. (1); Custom Hospitals Products (1); Storer Medical Products (1); General Cardiac Technology, Inc. (1); Procter & Gamble Mfg. Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KMO
- Run a recall and safety report across every KMO manufacturer
- Watch product code KMO 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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