510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242152Substantially Equivalent

SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

Epic Medical Pte., Ltd., Singapore, SG / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242152 is the FDA 510(k) clearance record for SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141), a class II device, cleared for Epic Medical Pte. , Ltd. on under FDA product code MEB (Pump, Infusion, Elastomeric). FDA records list 22 510(k) clearances for Epic Medical Pte. , Ltd., from to . As of , FDA records show no recalls naming K242152.

Clearance record

Decision date
Received
(76 days to decision)
Product code
MEB Pump, Infusion, Elastomeric
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Epic Medical Pte. , Ltd. 105 Cecil St. #20-04, Singapore, SG
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEB

Trailing 12 months
1 clearance under product code MEB 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 MEB, 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 20260
October 20260