Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgilite Intl., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
35 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823671 | NO-GAUZE LAPAROTOMY SPONGE | Surgilite Intl., Inc. | 1983-01-09 | 33 | 0 |
| K822482 | SURGILITE NON-WOVEN WRAP | Surgilite Intl., Inc. | 1982-09-21 | 35 | 0 |
| K822481 | MULTIPLE SURGICAL MASK | Surgilite Intl., Inc. | 1982-09-17 | 31 | 0 |
| K822483 | MULTIPLE SCRUB SUIT | Surgilite Intl., Inc. | 1982-09-17 | 31 | 0 |
| K771531 | LAPAROTOMY SPONGES | Surgilite Intl., Inc. | 1977-09-06 | 28 | 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