Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
ODF — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
240 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092739 | MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSC | C-Link Micro Imaging, Inc. | 2010-01-12 | 126 | 0 |
| K091962 | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OP | Lumenis, Inc. | 2009-09-30 | 91 | 0 |
| K090170 | SPYSCOPE ACCESS AND DELIVERY CATHETER | Boston Scientific Corp | 2009-02-04 | 12 | 0 |
| K052194 | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR | Boston Scientific Corp | 2005-08-24 | 13 | 2 |
| K050403 | SPYGLASS DIRECT VISULATION PROBE | Boston Scientific Corp | 2005-03-04 | 15 | 0 |
| K963354 | 5 STAR MEDICAL ENDOSCOPE | Five Star Medical, Inc. | 1997-09-08 | 378 | 0 |
| K943593 | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM | Ovamed Corp. | 1995-03-22 | 240 | 0 |
| K941230 | MINI-UB ENDOSCOPES | Candela Laser Corp. | 1994-06-17 | 94 | 0 |
| K933106 | ENDOSCOPE | Origin Medsystems, Inc. | 1993-10-19 | 116 | 0 |
| K912089 | MODIFIED SERIES 2100 ENDOSCOPES | Medical Laser, Inc. | 1991-08-12 | 91 | 0 |
| K910732 | CANDELA MINI-UB ENDOSCOPE | Candela Laser Corp. | 1991-04-12 | 50 | 0 |
| K874858 | LASERTRIPTER MINISCOPE | Candela Laser Corp. | 1988-02-19 | 86 | 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