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

Promex, Inc. — Predicate Candidate Screening

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

57 daysmedian FDA review time
90 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023450BIOPSY SITE TISSUE MARKER DEVICEPromex, Inc.2002-12-19650
K022634CO-AXIAL INTRODUCER NEEDLEPromex, Inc.2002-11-06900
K010400VACUUM ASSISTED CORE BIOPSY DEVICEPromex, Inc.2001-07-241625
K011270AUTOMATED CORE BIOPSY DEVICEPromex, Inc.2001-06-22570
K001132BONE BIOPSY NEEDLEPromex, Inc.2000-05-01210
K994272AUTOMATED CORE BIOPSY DEVICEPromex, Inc.2000-01-07180
K993435MANUAL BONE MARROW BIOPSY DEVICEPromex, Inc.1999-12-06551
K973184PROSTATE SEEDING NEEDLEPromex, Inc.1997-11-21880
K972865PROMEX ENT TISSUE REMOVAL SYSTEMPromex, Inc.1997-09-29560
K961078AUTOMATED VITRECTOMY DEVICEPromex, Inc.1996-06-14880
K960023KIRSHNER WIRES (K-WIRE) & STEINMANN PINSPromex, Inc.1996-03-18760
K960405SPINAL NEEDLEPromex, Inc.1996-02-28300
K955168SURGICAL CUTTERPromex, Inc.1996-01-22701
K954265TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLEPromex, Inc.1995-09-29170
K954231AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENTPromex, Inc.1995-09-22110
K954155GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLEPromex, Inc.1995-09-1270
K945146CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEPromex, Inc.1994-12-21620
K945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.1994-11-22340

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