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

Annex Medical, Inc. — Predicate Candidate Screening

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

76 daysmedian FDA review time
168 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954377FORCEPS, GRASPING, FLEXIBLE ENDOSCOPICAnnex Medical, Inc.1995-10-26370
K952863FORCEPS, BIOPSY, NON-ELECTRICAnnex Medical, Inc.1995-07-19270
K951532METAL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.1995-07-191070
K951761METEL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.1995-05-11240
K934636ANNEX MEDICAL FLAT WIRE STONE EXTRACTORAnnex Medical, Inc.1994-02-251510
K934598GRASPING FORCEPS OR RETRIEVAL FORCEPSAnnex Medical, Inc.1994-01-071050
K934675METAL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.1994-01-071010
K925267GRASPING FORCEPS OR RETRIEVAL FORCEPSAnnex Medical, Inc.1993-02-101140
K925559BILIARY STONE DISLODGERAnnex Medical, Inc.1992-12-17440
K921401BIOPSY FORCEPSAnnex Medical, Inc.1992-10-212110
K924027DISLODGER, STONE, BASKET, URETERAL, METALAnnex Medical, Inc.1992-10-20700
K922851CYTOLOGY BRUSHAnnex Medical, Inc.1992-08-25820
K922678LOOP RETRIEVERAnnex Medical, Inc.1992-08-25820
K914112METAL URETERAL BASKET STONE DISLODGER, FLAT WIREAnnex Medical, Inc.1992-02-281680
K914111METAL URETERAL BASKET STONE DISLODGER, HELICALAnnex Medical, Inc.1992-02-281680
K914110GRASPING FORCEPSAnnex Medical, Inc.1992-02-281680
K913248CYTOLOGY BRUSHAnnex Medical, Inc.1991-09-30700
K910603LOOP RETRIEVERAnnex Medical, Inc.1991-03-11270
K902265FLEXIBLE SNAREAnnex Medical, Inc.1990-07-27670
K896992METAL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.1990-02-08590
K896058GRASPING FORCEPSAnnex Medical, Inc.1989-12-28710
K896169METAL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.1989-12-18540
K895098BIOPSY FORCEPSAnnex Medical, Inc.1989-10-30760

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