Atlas FDA

MINIMED 508 INSULIN PUMP

FDA 510(k) clearance K990801 · decided 1999-06-08

Clearance details

K-number
K990801
Device name
MINIMED 508 INSULIN PUMP
Applicant
Medtronic Minimed
Decision
Substantially Equivalent - Subject to Tracking Reg.
Date received
1999-03-10
Decision date
1999-06-08
Days to decision
90 days
Clearance type
Traditional
Product code
LZG
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Sylmar, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
MiniMed Insulin Pump, model # MMT-508 recall (Z-1581-2020)Medtronic MiniMed2020-03-26
Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, recall (Z-0177-2020)Medtronic Inc.2019-11-04

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