KPY — Shield, Protective, Personnel Class I
FDA product code KPY covers "Shield, Protective, Personnel", a Class I medical device regulated under 21 CFR 892.6500. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPY
- Device Class
- Class I
- Regulation Number
- 892.6500
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K110900 | bloxr corporation | DISPOSABLE THYROID COLLAR | June 24, 2011 |
| K962622 | medtec | INTRA-ORAL THERMOPLASTIC SHIELD | October 1, 1996 |
| K954456 | medtec | THERMOPLASTIC SHIELD | December 21, 1995 |
| K954146 | mallinckrodt medical | UTK-DTE AUTILARY SHIELD | December 6, 1995 |
| K953610 | aukland medical plastics | AUKULYTE | September 26, 1995 |
| K951004 | kenex | 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) | April 10, 1995 |
| K951003 | kenex | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) | April 3, 1995 |
| K940539 | standard imaging | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM | March 16, 1994 |
| K934206 | f. walter hanel | MAVIG ANGIO SHIELD MODELS 6290 & 6272 | October 7, 1993 |
| K912378 | davis lead aprons | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS | March 18, 1992 |
| K912326 | davis lead aprons | DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS | March 18, 1992 |
| K912327 | davis lead aprons | DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. | March 18, 1992 |
| K900970 | infab | RADIATION PROTECTION GLASSES | May 1, 1990 |
| K896511 | e.i. dupont de nemours and co | DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL | December 22, 1989 |
| K896289 | infab | RADIATION PROTECTION APRON | December 14, 1989 |
| K871502 | cis-us | PERSONNEL PROTECTIVE SHIELD | May 8, 1987 |
| K844160 | syncor intl | VENTIBOX | December 17, 1984 |
| K811677 | medi-physics inc. dba nycomed amersham imaging | KRYPTON CART | July 2, 1981 |
| K811068 | g.d. searle and | BYPASS COIL | May 27, 1981 |
| K810095 | moti enterprises | MOTI APRON | February 12, 1981 |