510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864327Substantially Equivalent

Model 304-S External Micro-Volume Infusion Pump

Medtronic, Inc., Sylmar CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864327 is the FDA 510(k) clearance record for MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP, a class I device, cleared for Medtronic Minimed on under FDA product code FRW (Scale, Patient). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K864327.

Clearance record

Decision date
Received
(94 days to decision)
Product code
FRW Scale, Patient
Regulation
21 CFR 880.2720
Device class
Class I
Review panel
General Hospital
Applicant
Medtronic Minimed 12744 San Fernando Rd., Sylmar CA
Third party review
No

Clearances, product code FRW

Trailing 12 months

FDA records hold no clearances under product code FRW in the trailing twelve months.

FDA records show no clearances under product code FRW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FRW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260