Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FXO · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
34 daysmedian FDA review time
201 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914615 | BTP(TM) CENTRALINE(TM) SUIT | Btp Industries, Inc. | 1992-05-05 | 201 | 0 |
| K891212 | APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE | Pro-Safe Professional Linens, Inc. | 1989-04-14 | 38 | 0 |
| K882282 | SUIT, SURGICAL | A Plus International, Inc. | 1988-06-23 | 23 | 0 |
| K865022 | SURGICAL GARMENTS | Ulti-Med Intl., Inc. | 1987-01-12 | 20 | 0 |
| K831207 | SPUNGUARD SCRUB SUIT | Kimberly-Clark Corp. | 1983-05-16 | 34 | 0 |
| K822483 | MULTIPLE SCRUB SUIT | Surgilite Intl., Inc. | 1982-09-17 | 31 | 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