Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Schoelly Imaging, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
333 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090800 | VS-100 ILLUMINATION AND IMAGING SYSTEM | Schoelly Imaging, Inc. | 2009-05-18 | 55 | 0 |
| K090601 | FSC 2 | Schoelly Imaging, Inc. | 2009-05-11 | 67 | 0 |
| K083553 | NASO-LARYNGO-PHARYNGOSCOPE | Schoelly Imaging, Inc. | 2009-01-16 | 46 | 0 |
| K060899 | FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE | Schoelly Imaging, Inc. | 2007-03-02 | 333 | 0 |
| K053412 | FLEXISCOPE, MODELS 50MH AND 50 MHC | Schoelly Imaging, Inc. | 2006-02-23 | 78 | 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