Atlas FDA

MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP

FDA 510(k) clearance K041318 · decided 2004-07-19

Clearance details

K-number
K041318
Device name
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
Applicant
Medtronic Minimed
Decision
Substantially Equivalent
Date received
2004-05-18
Decision date
2004-07-19
Days to decision
62 days
Clearance type
Special
Product code
LZG
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Northridge, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic Minimed

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Pivot Insulin Delivery System (K253534)Modular Medical2026-04-08
Modular Medical MODD1 Insulin Delivery System (K240158)Modular Medical, Inc.2024-09-04
Extended Reservoir; MiniMed Reservoir (K241622)Medtronic Minimed2024-07-02
Omnipod GO Insulin Delivery Device (K223372)Insulet Corporation2023-04-24
Extended Reservoir (K210714)Medtronic Minimed, Inc.2022-04-06
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (K211575)Insulet Corporation2021-08-13
Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K192659)Insulet Corporation2019-10-21
Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K182630)Insulet Corporation2019-01-08
Omnipod DASH Insulin Management System (K180045)Insulet Corporation2018-06-01
OmniPod Insulin Management System (K162296)Insulet Corporation2017-04-18
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (K162080)Tandem Diabetes Care, Inc.2016-10-25
t:slim Insulin Delivery System (K160056)Tandem Diabetes Care, Inc.2016-07-25

Recalls involving this device

RecordFirmDate
MiniMed Paradigm Model 511 Insulin Pump recall (Z-1582-2020)Medtronic MiniMed2020-03-26

PMA approvals by this applicant

RecordFirmDate
Simplera System (P160007/S059)Medtronic Minimed2025-12-08
Simplera System (P160007/S057)Medtronic Minimed2025-12-05
Medtronic MiniMed 630G System (P150001/S110)Medtronic Minimed2025-10-16
Guardian Connect System Simplera System (P160007/S056)Medtronic Minimed2025-10-16
Guardian Connect System (P160007/S054)Medtronic Minimed2025-10-09
Simplera System (P160007/S055)Medtronic Minimed2025-09-12
Guardian Connect system (P160007/S053)Medtronic Minimed2025-08-25
Simplera (TM) System (P160007/S052)Medtronic Minimed2024-09-17