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

Medtronic MiniMed · Predicate Candidate Screening

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

77 daysmedian FDA review time

177 days90th percentile

49clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261962	SmartGuard Technology; Predictive Low Glucose Technology	Medtronic MiniMed	2026-07-09	28	0
K253701	SmartGuard Technology; Predictive Low Glucose Technology	Medtronic Minimed	2026-02-03	71	0
K253512	MiniMed Go App	Medtronic Minimed	2026-01-08	63	1
K242775	InPen System App (MMT-8060 (iOS), MMT-8061 (Android))	Medtronic Minimed	2024-11-12	60	3
K241622	Extended Reservoir; MiniMed Reservoir	Medtronic Minimed	2024-07-02	27	0
K160860	MiniMed Quick-serter	Medtronic Minimed	2016-09-22	177	0
K120206	MEDTRONIC MINIMED PARADIGM INSULIN PUMPS	Medtronic Minimed	2012-03-29	66	6
K100432	POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-	Medtronic Minimed	2010-07-09	143	0
K073356	PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT	Medtronic Minimed	2008-04-25	148	0
K053177	MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E	Medtronic Minimed	2006-01-31	78	4
K052431	MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1	Medtronic Minimed	2005-11-29	84	0
K052432	MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS	Medtronic Minimed	2005-11-29	84	0
K043600	MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C	Medtronic Minimed	2005-03-29	90	0
K041318	MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP	Medtronic Minimed	2004-07-19	62	1
K041317	MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN	Medtronic Minimed	2004-07-19	62	0
K040676	MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND	Medtronic Minimed	2004-05-21	67	2
K040061	MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL M	Medtronic Minimed	2004-04-08	86	0
K032484	MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT	Medtronic Minimed	2003-10-28	77	0
K032485	MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313	Medtronic Minimed	2003-10-28	77	0
K032164	DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333	Medtronic Minimed	2003-10-23	100	0
K032005	MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332	Medtronic Minimed	2003-08-22	53	1
K031917	MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 31	Medtronic Minimed	2003-08-19	57	0
K991936	3.0 ML RESERVOIR, MODEL 103/193	Medtronic Minimed	2000-01-18	223	0
K993012	MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311	Medtronic Minimed	1999-11-15	68	0
K991979	SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321	Medtronic Minimed	1999-09-03	81	0
K992300	QUICK-SERTER, MODEL 395	Medtronic Minimed	1999-07-29	21	0
K991013	MINIMED 407C INFUSION PUMP, MODEL 407C	Medtronic Minimed	1999-06-23	89	0
K990801	MINIMED 508 INSULIN PUMP	Medtronic Minimed	1999-06-08	90	2
K974163	MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316	Medtronic Minimed	1998-02-02	89	0
K972107	MINIMED INFUSION PUMP, MODEL 507C	Medtronic Minimed	1997-08-15	71	0
K963948	MINIMED INSULIN PUMP, MODEL 505	Medtronic Minimed	1997-04-08	188	0
K970479	MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300	Medtronic Minimed	1997-03-31	52	0
K965208	POLYFIN EXTENSION SET, MODELS 126 AND 128	Medtronic Minimed	1997-02-26	61	0
K964455	POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333	Medtronic Minimed	1997-01-30	85	0
K964456	POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 36	Medtronic Minimed	1997-01-30	85	0
K961474	POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133	Medtronic Minimed	1996-05-06	18	0
K960001	MINIMED INFUSION PUMP, MODEL MMT-507	Medtronic Minimed	1996-04-30	119	0
K954969	POLYFIN QR SUBCUTANEOUS INFUSION SET	Medtronic Minimed	1996-02-22	115	0
K942181	SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116	Medtronic Minimed	1994-07-14	71	0
K922670	THE MINIMED MODEL 404-SP AND 504-S	Medtronic Minimed	1993-09-16	521	0
K912458	MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED	Medtronic Minimed	1991-06-24	31	0
K901588	MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP	Medtronic Minimed	1990-07-02	88	0
K895436	MODIFIED MINIMED III INFUSION PUMP	Medtronic Minimed	1990-05-24	289	0
K890457	MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP	Medtronic Minimed	1989-03-08	37	0
K880623	MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP	Medtronic Minimed	1988-04-21	65	0
K874564	MINIMED III INFUSION PUMP & UNI-SET ADMIN SET	Medtronic Minimed	1988-02-11	99	0
K864327	MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP	Medtronic Minimed	1987-02-06	94	0
K864138	MINIMED MODEL 404-S EXTERNAL INFUSION PUMP	Medtronic Minimed	1986-12-29	69	0
K864517	MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS	Medtronic Minimed	1986-12-12	25	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