Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KPY — Predicate Candidate Screening
25 FDA 510(k) clearances under this product code; the 50 most recent screened below.
47 daysmedian FDA review time
294 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110900 | DISPOSABLE THYROID COLLAR | Bloxr Corporation | 2011-06-24 | 85 | 0 |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | Medtec, Inc. | 1996-10-01 | 88 | 0 |
| K954456 | THERMOPLASTIC SHIELD | Medtec, Inc. | 1995-12-21 | 87 | 0 |
| K954146 | UTK-DTE AUTILARY SHIELD | Mallinckrodt Medical | 1995-12-06 | 92 | 0 |
| K953610 | AUKULYTE | Aukland Medical Plastics, Inc. | 1995-09-26 | 55 | 0 |
| K951004 | 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & | Kenex , Ltd. | 1995-04-10 | 54 | 0 |
| K951003 | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) | Kenex , Ltd. | 1995-04-03 | 47 | 0 |
| K940539 | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM | Standard Imaging, Inc. | 1994-03-16 | 37 | 0 |
| K934206 | MAVIG ANGIO SHIELD MODELS 6290 & 6272 | F. Walter Hanel GmbH | 1993-10-07 | 38 | 0 |
| K912326 | DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 | 299 | 0 |
| K912327 | DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. | Davis Lead Aprons, Inc. | 1992-03-18 | 299 | 0 |
| K912378 | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 | 294 | 0 |
| K900970 | RADIATION PROTECTION GLASSES | Infab Corp. | 1990-05-01 | 60 | 0 |
| K896511 | DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL | E.I. Dupont DE Nemours & Co., Inc. | 1989-12-22 | 38 | 0 |
| K896289 | RADIATION PROTECTION APRON | Infab Corp. | 1989-12-14 | 44 | 0 |
| K871502 | PERSONNEL PROTECTIVE SHIELD | Cis-Us, Inc. | 1987-05-08 | 21 | 0 |
| K844160 | VENTIBOX | Syncor Intl. Corp. | 1984-12-17 | 54 | 0 |
| K811677 | KRYPTON CART | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-07-02 | 17 | 0 |
| K811068 | BYPASS COIL | G.D. Searle and Co. | 1981-05-27 | 40 | 0 |
| K810095 | MOTI APRON | Moti Enterprises, Inc. | 1981-02-12 | 29 | 0 |
| K802377 | MOTI PROTECTIVE X-RAY MASK | Moti Enterprises, Inc. | 1980-10-31 | 31 | 0 |
| K791522 | FLOW MEDICAL X-RAY PROTECTIVE GLOVES | Flow X-Ray Corp. | 1979-10-26 | 77 | 0 |
| K790639 | GONAD SHIELD | The Mochlett Laboratories, Inc. | 1979-04-23 | 24 | 0 |
| K790080 | APRON, LEADED VINYL | Pinnacle Distributors, Inc. | 1979-01-26 | 14 | 0 |
| K781852 | GLOVE, SUPERFLEX MOLDED | Pinnacle Distributors, Inc. | 1978-11-15 | 9 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda