510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K931458Substantially Equivalent

Medipak Ambulatory Infusion Pump

Medication Delivery Devices, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931458 is the FDA 510(k) clearance record for MEDIPAK AMBULATORY INFUSION PUMP, a class II device, cleared for Medication Delivery Devices, Inc. on under FDA product code FRN (Pump, Infusion). FDA records list one 510(k) clearance for Medication Delivery Devices, Inc. As of , FDA records show no recalls naming K931458.

Clearance record

Decision date
Received
(373 days to decision)
Product code
FRN Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Medication Delivery Devices, Inc. 6404 Nancy Ridge Dr., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code FRN

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