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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Protectaide, Inc. — Predicate Candidate Screening

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

146 daysmedian FDA review time
159 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942469PROTECTAIDE CPR PROTECTION PACKProtectaide, Inc.1994-10-311590
K942468PROTECTAIDE CPR PROTECTION PACK NO. 22100Protectaide, Inc.1994-10-311590
K942470PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315Protectaide, Inc.1994-10-181460
K942473PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592Protectaide, Inc.1994-10-181460
K942471PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777Protectaide, Inc.1994-10-181460
K942476PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069Protectaide, Inc.1994-10-181460
K942472PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123Protectaide, Inc.1994-10-181460
K942475PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351Protectaide, Inc.1994-10-181460
K942474PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000Protectaide, Inc.1994-10-181460
K942466PROTECTAIDE CPR PROTECTION PACK NO. 17701Protectaide, Inc.1994-10-061340
K942467PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000Protectaide, Inc.1994-10-061340

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