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

Meadox Surgimed, Inc. · Predicate Candidate Screening

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

91 daysmedian FDA review time

176 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K944143	MS CLASSIQUE BALLOON CATHETER	Meadox Surgimed, Inc.	1995-03-13	200
K945061	NOPROFILE OLBERT CATHETER SYSTEM	Meadox Surgimed, Inc.	1995-03-09	146
K942382	MS AMPLATZ EXTRA STIFF GUIDE WIRE	Meadox Surgimed, Inc.	1994-08-22	95
K930201	ACECUT SUTOMATIC BIOPSY SYSTEM	Meadox Surgimed, Inc.	1993-06-09	146
K911635	MEADOX(R) SURGIMED(R) BIOPSY GUN II	Meadox Surgimed, Inc.	1991-06-20	70
K905181	NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY	Meadox Surgimed, Inc.	1991-03-06	107
K904582	QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE	Meadox Surgimed, Inc.	1991-02-25	139
K904983	MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY	Meadox Surgimed, Inc.	1991-01-30	89
K902461	MEADOX SURGIMED BIOPSY GUN AND NEEDLE	Meadox Surgimed, Inc.	1990-07-16	42
K890926	SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE	Meadox Surgimed, Inc.	1989-06-20	116
K863218	CYTOSTATIC FILTRATION SET	Meadox Surgimed, Inc.	1987-02-12	176
K861267	UROCUT BIOPSY NEEDLE	Meadox Surgimed, Inc.	1987-01-20	291
K862742	NEPHROSTOMY SET	Meadox Surgimed, Inc.	1986-10-31	102
K862550	OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE	Meadox Surgimed, Inc.	1986-09-02	61
K860430	THE NAVIGATOR STEERABLE GUIDE WIRE	Meadox Surgimed, Inc.	1986-07-18	164
K861220	LUNDERQUIST - RING PTC DRAINAGE CATHETER	Meadox Surgimed, Inc.	1986-05-19	48
K860429	MEADOX SURGIMED GUIDE CATHETER	Meadox Surgimed, Inc.	1986-04-23	78
K854262	MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY	Meadox Surgimed, Inc.	1985-12-24	62
K854404	ROTEX SCREW BIOPSY NEEDLE	Meadox Surgimed, Inc.	1985-12-02	31
K854420	MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL	Meadox Surgimed, Inc.	1985-11-22	18
K851647	OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO	Meadox Surgimed, Inc.	1985-07-03	72
K851463	OLBERT CATHETER SYS FOR URETERAL DILATION	Meadox Surgimed, Inc.	1985-05-23	38
K843798	MEADOX SURGIMED A/S CATHETER SHEATH SYS	Meadox Surgimed, Inc.	1984-12-27	91
K841704	THINWALL PUNCTURE NEEDLE	Meadox Surgimed, Inc.	1984-06-28	66

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