FDA product code KCP: Syringe, Ent
KCP is the FDA product code for syringe, ent. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under KCP, from 4 different applicants. The average 510(k) review took 44 days (median 32). FDA has posted 1 recall for KCP devices.
Classification
| Field | Value |
|---|---|
| Device name | Syringe, Ent |
| Device class | Class I |
| Regulation | 21 CFR 874.5220 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KCP clearance
Top KCP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Imm Enterprises , Ltd. | 1 | 1984-05-09 |
| American Hospital Supply Corp. | 1 | 1982-10-04 |
| R. Wolf Medical Instruments Corp. | 1 | 1981-03-11 |
| Abco Dealers, Inc. | 1 | 1978-04-19 |
Most recent KCP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840311 | Imm Enterprises , Ltd. | CAT. 7-EAR, NOSE & THROAT DEVICES | 1984-05-09 | 106 |
| K822754 | American Hospital Supply Corp. | EAR/ULCER SYRINGE | 1982-10-04 | 26 |
| K810284 | R. Wolf Medical Instruments Corp. | AUTOMATIC TEFLON INJECTION SYRINGE | 1981-03-11 | 37 |
| K780599 | Abco Dealers, Inc. | SYRINGE, EAR & ULCER | 1978-04-19 | 9 |
Recalls for KCP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-04-30.
Frequently asked questions
What is FDA product code KCP?
KCP is the FDA product code for syringe, ent. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel.
What device class is KCP?
Class I, regulation 21 CFR 874.5220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCP?
Across 4 cleared submissions the average was 44 days from receipt to decision (median 32).
Which companies have the most KCP clearances?
Imm Enterprises , Ltd. (1); American Hospital Supply Corp. (1); R. Wolf Medical Instruments Corp. (1); Abco Dealers, Inc. (1).
Have KCP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KCP
- Run a recall and safety report across every KCP manufacturer
- Watch product code KCP 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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