Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pro-Safe Professional Linens, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
220 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891210 | POCKETED WRAPS #3009 A,B,C | Pro-Safe Professional Linens, Inc. | 1989-10-13 | 220 | 0 |
| K891216 | DENTAL EQUIPMENT PROTECTION DEVICES | Pro-Safe Professional Linens, Inc. | 1989-06-02 | 87 | 0 |
| K891211 | SURGICAL GOWN #2001 | Pro-Safe Professional Linens, Inc. | 1989-04-14 | 38 | 0 |
| K891213 | SURGICAL INSTRUMENT POUCH #M102 | Pro-Safe Professional Linens, Inc. | 1989-04-14 | 38 | 0 |
| K891214 | DENTAL SURGICAL WRAP #3007 A,B,C | Pro-Safe Professional Linens, Inc. | 1989-04-14 | 38 | 0 |
| K891215 | FAST WRAP #M 101 | Pro-Safe Professional Linens, Inc. | 1989-04-14 | 38 | 0 |
| K891212 | APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE | Pro-Safe Professional Linens, Inc. | 1989-04-14 | 38 | 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