510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K260001Substantially Equivalent

Mint ACE Pump

Beta Bionics, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(252 days to decision)
Product code
QFG Alternate Controller Enabled Insulin Infusion Pump
Regulation
21 CFR 880.5730
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Beta Bionics, Inc. 11 Hughes, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFG

Trailing 12 months
6 clearances under product code QFG in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QFG, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260