Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Camtronics, Ltd. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
196 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021236 | SURGERY AND ACCESSORIES | Camtronics, Ltd. | 2002-07-17 | 90 | 0 |
| K013032 | PHYSIOLOG, SERIES 95000 | Camtronics, Ltd. | 2002-06-04 | 267 | 0 |
| K992666 | VIDEO PLUS SYSTEM, SERIES 95000 | Camtronics, Ltd. | 1999-10-13 | 65 | 0 |
| K992259 | ECHOCARDIOGRAPHY SYSTEM SERIES 95000 | Camtronics, Ltd. | 1999-09-08 | 64 | 0 |
| K990066 | CCD CAMERA, MODEL 9000 | Camtronics, Ltd. | 1999-03-17 | 68 | 2 |
| K955519 | ANALYTICAL REVIEW STATION | Camtronics, Ltd. | 1996-05-09 | 157 | 1 |
| K954159 | DIGITAL IMAGING SYSTEM | Camtronics, Ltd. | 1996-03-19 | 196 | 0 |
| K955232 | NT SERIES DIGITAL IMAGE MANAGER | Camtronics, Ltd. | 1995-12-11 | 27 | 0 |
| K953080 | DIGITAL IMAGING SYSTEM INTERFACE | Camtronics, Ltd. | 1995-09-28 | 87 | 0 |
| K945654 | NICOM DIGITAL IMAGE MANAGER | Camtronics, Ltd. | 1995-02-17 | 92 | 0 |
| K941979 | VIDEO PLUS WITH ANALYTICAL WORKSTATION | Camtronics, Ltd. | 1994-08-17 | 114 | 0 |
| K934496 | X-RAY ANGIOGRAPHIC SYSTEM | Camtronics, Ltd. | 1993-12-13 | 89 | 0 |
| K922647 | COLOR DISKSTORE | Camtronics, Ltd. | 1992-08-11 | 69 | 0 |
| K912341 | MULTICAM I 8X10 | Camtronics, Ltd. | 1991-08-26 | 94 | 0 |
| K884148 | DISKCAM DC 6001 | Camtronics, Ltd. | 1988-11-23 | 51 | 0 |
| K871743 | VIDEO PLUS MODELS VP500, VP500A AND VP1000 | Camtronics, Ltd. | 1987-06-22 | 48 | 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