Atlas FDA

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

INP — Predicate Candidate Screening

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

25 daysmedian FDA review time
27 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K831889SURGEON'S CHOICE CRUTCH HANDLEW.K. Wheeler, Inc.1983-07-07230
K831149PERSONAL KNEE CRUTCH PADTecnol New Jersey Wound Care, Inc.1983-05-03250
K811493CRUTCH & WALKER PADSFred Sammons, Inc.1981-06-12170
K810650CRUTCH TIPS & GRIPSFirst Industries, Inc.1981-03-26160
K803136CONPHAR CRUTCH TIPSConphar, Inc.1981-01-08270
K803140CONPHAR CRUTCH GRIPSConphar, Inc.1981-01-08270
K803144CONPHAR CRUTCH PADSConphar, Inc.1981-01-08270
K800076CRUTCH TIPS, PADS & HAND GRIPSNew World Imports, Inc.1980-01-28140

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