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

Tava Surgical Instruments — Predicate Candidate Screening

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

39 daysmedian FDA review time
168 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K935367TAVA WIRE-DRIVERTava Surgical Instruments1994-04-211680
K940109TAVA K-WIRETava Surgical Instruments1994-02-22430
K885273MICRO SURGICAL INSTRUMENT SYSTEMTava Surgical Instruments1989-01-30390
K884492MICRO SURGICAL INSTRUMENT SYSTEMTava Surgical Instruments1988-11-16210
K872475SURGICAL BURTava Surgical Instruments1987-07-0290
K863788SAWBLADETava Surgical Instruments1986-10-14180
K854543PULSE LAVAGETava Surgical Instruments1986-01-27750

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