Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GDC — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
29 daysmedian FDA review time
119 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971390 | QUANTUM 3080SP SURGICAL TABLE | STERIS Corporation | 1997-05-15 | 31 | 0 |
| K970807 | MOBILE OPERATING TABLE 1132.01 | Stierlen-Maquet AG | 1997-03-14 | 9 | 0 |
| K964273 | DURA-BOARD ARMBOARD | Allen Medical Systems, Inc. | 1997-01-08 | 72 | 0 |
| K940616 | SKYTRON ELITE 3500 TABLE | Skytron, Div. the Kmw Group, Inc. | 1994-06-13 | 119 | 0 |
| K934744 | MIDMARK MAGNUM GENERAL SURGICAL TABLE | Midmark Corp. | 1994-03-28 | 175 | 0 |
| K914758 | MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE | Mdt Corp., Inc. | 1991-12-19 | 58 | 0 |
| K915393 | MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE | Mdt Corp., Inc. | 1991-12-17 | 18 | 0 |
| K883613 | OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. | Stierlen-Maquet AG | 1988-09-15 | 24 | 0 |
| K853720 | MOBILE OPERATING TABLE FOR ORL MICROSURGERY | Carl Zeiss, Inc. | 1985-10-18 | 43 | 0 |
| K853480 | SKYTRON ELITE 6000 & 6001 SURGICAL TABLES | Skytron, Div. the Kmw Group, Inc. | 1985-09-12 | 23 | 0 |
| K853535 | TRAUMA TABLE | Xre Corp. | 1985-09-11 | 19 | 0 |
| K851021 | MAYFIELD TABLE-ELECTRIC | Ohio Medical Instrument Co., Inc. | 1985-05-21 | 70 | 0 |
| K851830 | SKYTRON ELITE 7000 MICRO-SURGERY TABLE | Skytron, Div. the Kmw Group, Inc. | 1985-05-17 | 21 | 0 |
| K851829 | SKYTRON ELITE 3100 SURGICAL TABLE | Skytron, Div. the Kmw Group, Inc. | 1985-05-17 | 21 | 0 |
| K850168 | STILLE SCANDIA OPERATING TABLES RC 3000,1100 | Stille-Werner (Usa), Inc. | 1985-03-28 | 71 | 0 |
| K843134 | MOBILE OPERATING TABLE HEIDELBERGS 1130 | Stierlen-Maquet AG | 1984-09-07 | 29 | 0 |
| K821749 | AMSCO ENDOSCOPY TABLE | American Sterilizer Co. | 1982-07-09 | 24 | 0 |
| K821665 | PEDESTAL EXAMINING TABLE | American Hamilton | 1982-06-24 | 20 | 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