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

Minimed, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time

186 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K031541	PARADIGMPAL, MODEL MMT-7330	Minimed, Inc.	2003-11-18	186	0
K031390	MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712	Minimed, Inc.	2003-07-23	82	2
K030531	MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD	Minimed, Inc.	2003-06-17	118	2
K021974	MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MO	Minimed, Inc.	2002-08-06	50	0
K010377	MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385	Minimed, Inc.	2001-04-05	56	0
K001828	PARADIGM 1.5ML RESERVOIR, MODEL 326	Minimed, Inc.	2000-08-18	63	1
K001832	PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318	Minimed, Inc.	2000-08-18	63	0
K001827	PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325	Minimed, Inc.	2000-08-18	63	0
K001829	MINIMED PARADIGM INSULIN PUMP, MODEL 511	Minimed, Inc.	2000-08-18	63	3

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