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

Medtronic — Predicate Candidate Screening

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

90 daysmedian FDA review time

222 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253530	Trexon™ Monofilament Synthetic Absorbable Suture	Medtronic	2026-05-28	196	0
K251744	Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Af	Medtronic	2026-01-16	224	0
K233433	Sphere-9Dx Diagnostic Catheter (AFR-00009)	Medtronic	2024-08-07	300	0
K240190	MYOtherm XP Cardioplegia Delivery System with Cortiva BioAct	Medtronic	2024-02-23	30	0
K223494	CD Horizon Spinal System	Medtronic	2023-01-23	63	0
K223178	SelectSite C304 Deflectable Catheter System, C315 Delivery S	Medtronic	2022-11-08	28	0
K222873	Attain Command + SureValve Delivery System, Attain Select II	Medtronic	2022-11-07	46	0
K221244	CD Horizon™ Spinal System	Medtronic	2022-05-25	23	0
K203111	Affinity Fusion Oxygenator System, Affinity Pixie Oxygenatio	Medtronic	2021-09-16	336	6
K211596	CD Horizon Spinal System	Medtronic	2021-06-23	30	0
K210637	CD Horizon™ Spinal System	Medtronic	2021-04-30	58	0
K210449	Infinity™ OCT System, PASS OCT® Spinal System	Medtronic	2021-03-18	30	0
K202771	CD Horizon Spinal System	Medtronic	2020-10-19	28	0
K201362	CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System	Medtronic	2020-08-19	89	0
K200514	Cardioblate Gemini-s Surgical Ablation Device	Medtronic	2020-06-03	93	0
K191851	VS3-IR	Medtronic	2019-11-25	138	0
K190716	Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, St	Medtronic	2019-08-08	142	0
K183547	Marinr Steerable Intracardiac Electrode Catheter, StableMapr	Medtronic	2019-07-30	222	0
K190132	Torqr Intracardiac Electrode Catheter, Soloist Intracardiac	Medtronic	2019-07-30	183	0
K190623	Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen	Medtronic	2019-05-30	80	0
K183453	VS3-IR	Medtronic	2019-03-04	81	0
K182610	Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Sur	Medtronic	2018-12-19	89	0
K181132	Tri-Ad 2.0 Adams Tricuspid Band	Medtronic	2018-05-29	29	0
K171938	KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set	Medtronic	2017-10-23	117	0
K171253	Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, St	Medtronic	2017-05-25	27	0
K161249	Streamline 6495 Bipolar Temporary Myocardial Pacing Lead	Medtronic	2016-08-19	108	0
K151227	KYPHON XPEDE Bone Cement	Medtronic	2015-11-16	193	0
K132623	MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE	Medtronic	2013-12-19	119	0
K123771	KYPHON EXPRESS II INFLATABLE BONE TAMPS	Medtronic	2012-12-21	14	0
K102397	KYPHON XPEDE BONE CEMENT	Medtronic	2011-02-28	188	0
K101864	KYPHON XPANDER II INFLATABLE BONE TAMP	Medtronic	2010-10-14	104	0
K090721	CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENS	Medtronic	2009-06-16	90	0
K070286	BIO-CONSOLE, MODEL 560	Medtronic	2007-05-22	113	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