Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LPZ · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
174 daysmedian FDA review time
817 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021702 | CRYOBAG, MODEL CB | Origen Biomedical, Inc. | 2002-08-06 | 75 | 0 |
| K915471 | CRYOBAG | Janus Biomedical, Inc. | 1994-03-02 | 817 | 0 |
| K863872 | TAMPER HAMPER | Hydro-Med Products, Inc. | 1987-02-10 | 130 | 0 |
| K861761 | ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE | Travenol Laboratories, S.A. | 1986-08-28 | 114 | 0 |
| K860511 | AMPU-PAK | Ammerman Medical Enterprises, Inc. | 1986-08-04 | 174 | 0 |
| K853663 | ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR | Travenol Laboratories, S.A. | 1986-04-09 | 218 | 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