Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Woodbine Optical Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
98 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970917 | SOLOS 10MM OPERATING LAPAROSCOPE | Woodbine Optical Corp. | 1997-06-10 | 90 | 0 |
| K970056 | SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES | Woodbine Optical Corp. | 1997-01-28 | 21 | 0 |
| K953086 | WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA | Woodbine Optical Corp. | 1995-09-22 | 81 | 0 |
| K951522 | WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAME | Woodbine Optical Corp. | 1995-06-16 | 74 | 0 |
| K940988 | ACCESSORIES, SURGICAL CAMERA | Woodbine Optical Corp. | 1994-06-10 | 98 | 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