Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KQM — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
32 daysmedian FDA review time
113 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900160 | ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER | Jedmed Instrument Co. | 1990-01-24 | 12 | 0 |
| K890826 | SONY VIDEO GRAPHIC PRINTER UP-850 | Sony Corp. of America | 1989-03-14 | 25 | 0 |
| K885042 | SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD | Sony Medical Electronics Co. | 1988-12-22 | 17 | 0 |
| K882958 | SONY VIDEO PRINTERS, UP SERIES | Sony Medical Electronics Co. | 1988-08-04 | 21 | 0 |
| K882924 | MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS | M.P. Video, Inc. | 1988-07-26 | 13 | 0 |
| K873419 | VIDEO PRINTER SYSTEM | Technology For Imaging, Inc. | 1987-11-02 | 68 | 0 |
| K871595 | SURGICAL CAMERA ACCESSORIES | M.P. Video, Inc. | 1987-05-07 | 13 | 0 |
| K863800 | ENDOSCOPIC VIDEO CAMERA | Technology For Imaging, Inc. | 1986-10-14 | 15 | 0 |
| K860904 | VIDEO PRINTER, MODEL 3200 | Medline Industries, Inc. | 1986-03-28 | 18 | 0 |
| K850749 | CONCEPT VIDEO IMAGING SYSTEM | Concept, Inc. | 1985-05-20 | 84 | 0 |
| K843806 | VIS-1000 VIDEO SYSTEM | Vistek Corp. | 1984-12-12 | 76 | 0 |
| K843295 | MED. DYNAMICS HIGH RESOLUTION SOLID ST | Medline Industries, Inc. | 1984-12-12 | 113 | 0 |
| K843294 | MED. DYNAMICS SATICAN VIDEO CAMERA 5410 | Medline Industries, Inc. | 1984-12-12 | 113 | 0 |
| K832342 | ENDOSCOPIC CAMERA TV W/AUDIO | Kamiya Tsusan Kaisha, Ltd. | 1983-09-12 | 62 | 0 |
| K820626 | OPTI-DISC | Video-Medical Devices, Ltd. | 1982-04-09 | 32 | 0 |
| K812405 | STERILE TV CAMERA & CORD COVER | Hydro-Med Products, Inc. | 1981-10-20 | 60 | 0 |
| K811717 | GATOR DRAPES | The Anspach Effort, Inc. | 1981-07-20 | 32 | 0 |
| K810512 | MEDISEAL CAMERA COVERS | Janin Group, Inc. | 1981-03-13 | 17 | 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