Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Sterilization, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
199 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984422 | STERILE BACK SURGICAL GOWN WITH HAND TOWEL | Medical Sterilization, Inc. | 1999-04-02 | 113 | 0 |
| K912803 | MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL | Medical Sterilization, Inc. | 1992-01-10 | 199 | 0 |
| K843564 | MSI SURGI-GRADE SUTURE TRAY | Medical Sterilization, Inc. | 1984-10-31 | 51 | 0 |
| K843562 | MSI SURGI-GRADE DELUXE CUT-DOWN TRAY | Medical Sterilization, Inc. | 1984-10-24 | 44 | 0 |
| K843561 | MSI SURGI-GRADE UNIVERSAL TRACH TRAY | Medical Sterilization, Inc. | 1984-10-24 | 44 | 0 |
| K843563 | MSI SURGI-GRADE INCISION & DRAIN TRAY | Medical Sterilization, Inc. | 1984-10-23 | 43 | 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