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

Medtronic Neurosurgery — Predicate Candidate Screening

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

90 daysmedian FDA review time

233 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243676	Duet External Drainage and Monitoring System (EDMS)	Medtronic Neurosurgery	2025-03-10	103	0
K242034	Duet External Drainage and Monitoring System (EDMS)	Medtronic Neurosurgery	2024-10-24	105	0
K212641	StrataMR II Valves and Shunts	Medtronic Neurosurgery	2021-09-16	27	0
K181622	StrataMR guider tool	Medtronic Neurosurgery	2018-10-01	103	0
K161370	Durepair Dura Regeneration Matrix	Medtronic Neurosurgery	2016-11-02	169	1
K152700	StrataMR Valves and Shunts	Medtronic Neurosurgery	2016-04-07	199	1
DEN120017	Medtronic DUET External Drainage and Monitoring System	Medtronic Neurosurgery	2014-08-22	609	0
K123524	MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM	Medtronic Neurosurgery	2013-02-13	90	0
K110560	MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER	Medtronic Neurosurgery	2011-11-18	263	0
K091312	PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM	Medtronic Neurosurgery	2009-09-02	121	0
K083076	STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHU	Medtronic Neurosurgery	2008-11-20	35	0
K082127	STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MOD	Medtronic Neurosurgery	2008-08-27	29	1
K073139	SMALL LUMEN PERITONEAL CATHETER	Medtronic Neurosurgery	2008-01-30	84	0
K063836	RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICUL	Medtronic Neurosurgery	2007-08-16	233	0
K062821	U-CLIP DEVICE	Medtronic Neurosurgery	2006-12-19	90	0
K063117	MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX	Medtronic Neurosurgery	2006-11-03	22	0
K060681	MEDTRONIC PS MEDICAL STRATA TYPE VALUE	Medtronic Neurosurgery	2006-09-15	184	1
K062348	TIMESH SELF DRILLING SCREW	Medtronic Neurosurgery	2006-09-08	28	0
K052386	MEDTRONIC M2 MAGNET ADJUSTMENT TOOL	Medtronic Neurosurgery	2005-12-16	107	0
K052211	DUREPAIR DURA REGENERATION MATRIX	Medtronic Neurosurgery	2005-09-14	30	0
K050044	MEDTRONIC CLIP GUN KIT	Medtronic Neurosurgery	2005-02-07	28	0
K041992	MEDTRONIC STRATAVARIUS	Medtronic Neurosurgery	2005-01-28	189	0
K042465	PS MEDICAL STRATA II VALVE	Medtronic Neurosurgery	2004-10-19	36	2
K042198	PS MEDICAL NEUROSURGICAL IMPLANTS	Medtronic Neurosurgery	2004-09-24	42	0
K041000	DUREPAIR DURA REGENERATION MATRIX	Medtronic Neurosurgery	2004-07-27	99	0
K040943	MEDTRONIC PS MEDICAL STRATA VALVE	Medtronic Neurosurgery	2004-06-15	64	0
K033850	MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES W	Medtronic Neurosurgery	2004-01-13	33	1
K013000	MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520	Medtronic Neurosurgery	2001-12-05	90	0

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