510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K990801Substantially Equivalent - Subject to Tracking Reg.

Minimed 508 Insulin Pump

Medtronic, Inc., Sylmar CA / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K990801 is the FDA 510(k) clearance record for MINIMED 508 INSULIN PUMP, a class II device, cleared for Medtronic Minimed on under FDA product code LZG (Pump, Infusion, Insulin). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show 2 recalls naming K990801.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LZG Pump, Infusion, Insulin
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Medtronic Minimed 12744 San Fernando Rd., Sylmar CA
Third party review
No

Clearances, product code LZG

Trailing 12 months
2 clearances under product code LZG in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LZG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260