Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sun Medical, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921963 | DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 | Sun Medical, Inc. | 1992-09-11 | 137 | 0 |
| K911154 | SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 | Sun Medical, Inc. | 1991-07-26 | 133 | 0 |
| K874948 | SUN MEDICAL SMOKE EVACUATOR SYSTEM | Sun Medical, Inc. | 1988-02-18 | 78 | 0 |
| K845006 | SUN MEDICAL LAMINARIA CERVICAL DILATOR | Sun Medical, Inc. | 1985-05-01 | 126 | 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