Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FWD — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
16 daysmedian FDA review time
29 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891236 | FDX SOLID STATE VIDEO CAMERA MODEL 5950 | Medical Dynamics, Inc. | 1989-04-05 | 29 | 0 |
| K882166 | JEDMED MICRO CCD CAMERA SYSTEM | Jedmed Instrument Co. | 1988-06-15 | 22 | 0 |
| K862664 | JEDMED CCD CAMERA SYSTEM | Jedmed Instrument Co. | 1986-07-30 | 16 | 0 |
| K862145 | JEDMED MINI-MOS VIDEO CAMERA | Jedmed Instrument Co. | 1986-06-13 | 9 | 0 |
| K862034 | JEDMED CCD-02 VIDEO CAMERA SYSTEM | Jedmed Instrument Co. | 1986-06-09 | 11 | 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