Product code KPY
- Device name
- Shield, Protective, Personnel
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.6500
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110900 | DISPOSABLE THYROID COLLAR | Bloxr Corporation | 2011-06-24 |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | Medtec, Inc. | 1996-10-01 |
| K954456 | THERMOPLASTIC SHIELD | Medtec, Inc. | 1995-12-21 |
| K954146 | UTK-DTE AUTILARY SHIELD | Mallinckrodt Medical | 1995-12-06 |
| K953610 | AUKULYTE | Aukland Medical Plastics, Inc. | 1995-09-26 |
| K951004 | 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) | Kenex , Ltd. | 1995-04-10 |
| K951003 | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) | Kenex , Ltd. | 1995-04-03 |
| K940539 | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM | Standard Imaging, Inc. | 1994-03-16 |
| K934206 | MAVIG ANGIO SHIELD MODELS 6290 & 6272 | F. Walter Hanel GmbH | 1993-10-07 |
| K912378 | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912327 | DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912326 | DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K900970 | RADIATION PROTECTION GLASSES | Infab Corp. | 1990-05-01 |
| K896511 | DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL | E.I. Dupont DE Nemours & Co., Inc. | 1989-12-22 |
| K896289 | RADIATION PROTECTION APRON | Infab Corp. | 1989-12-14 |
| K871502 | PERSONNEL PROTECTIVE SHIELD | Cis-Us, Inc. | 1987-05-08 |
| K844160 | VENTIBOX | Syncor Intl. Corp. | 1984-12-17 |
| K811677 | KRYPTON CART | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-07-02 |
| K811068 | BYPASS COIL | G.D. Searle and Co. | 1981-05-27 |
| K810095 | MOTI APRON | Moti Enterprises, Inc. | 1981-02-12 |
| K802377 | MOTI PROTECTIVE X-RAY MASK | Moti Enterprises, Inc. | 1980-10-31 |
| K791522 | FLOW MEDICAL X-RAY PROTECTIVE GLOVES | Flow X-Ray Corp. | 1979-10-26 |
| K790639 | GONAD SHIELD | The Mochlett Laboratories, Inc. | 1979-04-23 |
| K790080 | APRON, LEADED VINYL | Pinnacle Distributors, Inc. | 1979-01-26 |
| K781852 | GLOVE, SUPERFLEX MOLDED | Pinnacle Distributors, Inc. | 1978-11-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G031300FPNL0 | Full Pano Apron | Shielding International Inc. | 2023-08-14 |
| G031300CTL0 | Patient Apron | Shielding International Inc. | 2023-08-08 |
| G031300KKCNL0 | Kling Kuver Dental - | Shielding International Inc. | 2023-08-07 |
| G031300PPTL0 | Panoramic Poncho | Shielding International Inc. | 2023-08-07 |
| G031300PPRL0 | Panoramic Poncho | Shielding International Inc. | 2023-08-07 |
| G031300PPNL0 | Panoramic Poncho | Shielding International Inc. | 2023-08-07 |
| G031300PPLF0 | Panoramic Poncho | Shielding International Inc. | 2023-08-07 |
| G031300PPCTL0 | Panoramic Poncho | Shielding International Inc. | 2023-08-07 |
| G031300PPCRL0 | Panoramic Poncho | Shielding International Inc. | 2023-08-07 |
| G031300PPCNL0 | Panoramic Poncho | Shielding International Inc. | 2023-08-07 |
| G031300PPCLF0 | Panoramic Poncho | Shielding International Inc. | 2023-08-07 |
| G031300NL0 | Patient Apron | Shielding International Inc. | 2023-08-07 |
| G031300LF0 | Patient Apron | Shielding International Inc. | 2023-08-07 |
| G031300KKNL0 | Kling Kuver Dental - | Shielding International Inc. | 2023-08-07 |
| G031300KKLF0 | Kling Kuver Dental - | Shielding International Inc. | 2023-08-07 |
| G031300KKCTL0 | Kling Kuver Dental - | Shielding International Inc. | 2023-08-07 |
| G031300KKCRL0 | Kling Kuver Dental - | Shielding International Inc. | 2023-08-07 |
| G031300KKCLF0 | Kling Kuver Dental - | Shielding International Inc. | 2023-08-07 |
| G031300FPTL0 | Full Pano Apron | Shielding International Inc. | 2023-08-07 |
| G031300FPRL0 | Full Pano Apron | Shielding International Inc. | 2023-08-07 |
| G031300FPLF0 | Full Pano Apron | Shielding International Inc. | 2023-08-07 |
| G031300CRL0 | Patient Apron | Shielding International Inc. | 2023-08-07 |
| G031300CNL0 | Patient Apron | Shielding International Inc. | 2023-08-07 |
| G031300CLF0 | Patient Apron | Shielding International Inc. | 2023-08-07 |
| 08054301890459 | Xguard | EMERSON & CO SRL | 2018-03-16 |
| 08054301890442 | Xguard | EMERSON & CO SRL | 2018-03-16 |
| 08054301890435 | Xguard | EMERSON & CO SRL | 2018-03-16 |
| 08054301890206 | Protech Proguard | EMERSON & CO SRL | 2018-03-15 |
| 08054301890220 | Protech Proguard | EMERSON & CO SRL | 2018-03-15 |
| 08054301890213 | Protech Proguard | EMERSON & CO SRL | 2018-03-15 |