Atlas FDA

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

FZF · Predicate Candidate Screening

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

49 daysmedian FDA review time
103 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K881516COMPRESAIDR. Evans Corp.1988-04-29180
K874051INFLATABLE FULL LEG SPLINTVinyl Technology, Inc.1987-11-23490
K874050INFLATABLE FOOT & ANKLE SPLINTVinyl Technology, Inc.1987-11-23490
K874052INFLATABLE HALF LEG SPLINTVinyl Technology, Inc.1987-11-23490
K874053INFLATABLE FULL ARM SPLINTVinyl Technology, Inc.1987-11-23490
K853600INFLATABLE AIR SPLINTSHospitak, Inc.1985-09-19230
K831764URIAS PRESSURE SPLINTS, & FIRST AIDSvenol Andersen1983-09-121030

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