Atlas FDA

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

Trebay Medical Corp. · Predicate Candidate Screening

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

35 daysmedian FDA review time
54 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K955704TREBAY MICRODEBRIDER SYSTEMTrebay Medical Corp.1996-01-30460
K955560TREBAY SCOPE IRRIGATED CLEARING SLEEVETrebay Medical Corp.1995-12-22160
K955294SOF - ABRASION BURTrebay Medical Corp.1995-12-22350
K955447TYMPANOSTOMY TUBETrebay Medical Corp.1995-12-21220
K954912TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)Trebay Medical Corp.1995-12-06440
K954795AT2 & DOYLE STYLE (C-FLEX) VENT TUBESTrebay Medical Corp.1995-11-15280
K954796MICRO-INGRESSOR HANDIPIECETrebay Medical Corp.1995-11-06190
K954518TREBAY TOTAL RECTANGULAR HEADTrebay Medical Corp.1995-10-27290
K954517TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDITrebay Medical Corp.1995-10-27290
K954715MICRO-PLANER HANDPIECETrebay Medical Corp.1995-10-27150
K952226C-FLEX SEPTAL SPLINTSTrebay Medical Corp.1995-08-11910
K952609REDI DRILL DRILL SYSTEMTrebay Medical Corp.1995-07-31540
K952227C-FLEX ENDOLYMPHATIC SHUNTTrebay Medical Corp.1995-06-16350
K951526TREBAY IRRGATED CUTTER BLADETrebay Medical Corp.1995-05-12390

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