Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zander Medical Supplies, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
471 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041952 | ZIVF-AIRE | Zander Medical Supplies, Inc. | 2005-09-08 | 415 | 0 |
| K011327 | DB1 EMBRYO FREEZE | Zander Medical Supplies, Inc. | 2002-08-15 | 471 | 0 |
| K002971 | MTG - MINITUB HEATED STAGE SYSTEMS | Zander Medical Supplies, Inc. | 2000-12-15 | 84 | 0 |
| K002961 | MINITUB MULTI-PURPOSE CASSETTES | Zander Medical Supplies, Inc. | 2000-11-21 | 60 | 0 |
| K003184 | RS BIOTECH GALAXY 'R' CO2 INCUBATOR | Zander Medical Supplies, Inc. | 2000-11-20 | 40 | 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