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

Tisport · Predicate Candidate Screening

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

28 daysmedian FDA review time

121 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K023606	TILITE YG AND TILITE YGS	Tisport	2002-11-19	22	0
K020539	TIPOWER POWERDRIVE AND RIMPOWER X & SX	Tisport	2002-06-20	121	0
K020639	TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER	Tisport	2002-06-20	113	0
K990555	TISPORT X AND TISPORT XC	Tisport	1999-03-22	28	0
K990358	CROSS SPORT, RIGID WHEELCHAIR	Tisport	1999-02-26	21	1

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