Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Zee Medical Products Co., Inc. · Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

34 daysmedian FDA review time
58 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823501ZEE SPHYGMOMANOMETERZee Medical Products Co., Inc.1983-01-21580
K813156ULTRA-WIDE SAFETY SPECTACLE FRAMEZee Medical Products Co., Inc.1981-12-14380
K813016ZEE TRACTION SPLINTZee Medical Products Co., Inc.1981-11-24280
K812814ZEE SURGICAL INSTRUMENTSZee Medical Products Co., Inc.1981-11-06310
K812564ZEE LIFE SUPPORT AIR PANTSZee Medical Products Co., Inc.1981-10-23450
K812342ZEE EXTRICATION DEVICEZee Medical Products Co., Inc.1981-09-21340
K812284ZEE ELECTRODE-GELZee Medical Products Co., Inc.1981-09-08260
K812022ZEE MANUAL RESUSCITATORZee Medical Products Co., Inc.1981-07-31110

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