FDA product code KPY: Shield, Protective, Personnel
KPY is the FDA product code for shield, protective, personnel. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel. FDA has cleared 25 510(k) submissions under KPY, from 18 different applicants. The average 510(k) review took 77 days (median 47). FDA has posted 2 recalls for KPY devices.
Classification
| Field | Value |
|---|---|
| Device name | Shield, Protective, Personnel |
| Device class | Class I |
| Regulation | 21 CFR 892.6500 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KPY clearance
Top KPY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Davis Lead Aprons, Inc. | 3 | 1992-03-18 |
| Medtec, Inc. | 2 | 1996-10-01 |
| Kenex , Ltd. | 2 | 1995-04-10 |
| Infab Corp. | 2 | 1990-05-01 |
| Moti Enterprises, Inc. | 2 | 1981-02-12 |
13 more applicants have KPY clearances. See the full list in Caduvo.
Most recent KPY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110900 | Bloxr Corporation | DISPOSABLE THYROID COLLAR | 2011-06-24 | 85 |
| K962622 | Medtec, Inc. | INTRA-ORAL THERMOPLASTIC SHIELD | 1996-10-01 | 88 |
| K954456 | Medtec, Inc. | THERMOPLASTIC SHIELD | 1995-12-21 | 87 |
| K954146 | Mallinckrodt Medical | UTK-DTE AUTILARY SHIELD | 1995-12-06 | 92 |
| K953610 | Aukland Medical Plastics, Inc. | AUKULYTE | 1995-09-26 | 55 |
Recalls for KPY devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-03-09.
Frequently asked questions
What is FDA product code KPY?
KPY is the FDA product code for shield, protective, personnel. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.
What device class is KPY?
Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KPY?
Across 25 cleared submissions the average was 77 days from receipt to decision (median 47).
Which companies have the most KPY clearances?
Davis Lead Aprons, Inc. (3); Medtec, Inc. (2); Kenex , Ltd. (2); Infab Corp. (2); Moti Enterprises, Inc. (2).
Have KPY devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-03-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KPY
- Run a recall and safety report across every KPY manufacturer
- Watch product code KPY 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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