Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sis Ltd., Surgical Instrument Systems — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082871 | XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM | Sis Ltd., Surgical Instrument Systems | 2009-07-09 | 283 | 0 |
| K051940 | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | Sis Ltd., Surgical Instrument Systems | 2005-09-28 | 72 | 0 |
| K043150 | AMADEUS II EPIKERATOME | Sis Ltd., Surgical Instrument Systems | 2005-01-31 | 77 | 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