510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253976Substantially Equivalent

iLet ACE Pump

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

K253976 is the FDA 510(k) clearance record for iLet ACE Pump, a class II device, cleared for Beta Bionics, Inc. on under FDA product code QFG (Alternate Controller Enabled Insulin Infusion Pump). FDA's definition for product code QFG reads: "An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin...". FDA records list 6 510(k) clearances for Beta Bionics, Inc., from to . As of , FDA records show no recalls naming K253976.

Clearance record

Decision date
Received
(139 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. 300 Baker Ave., Suite 301, Concord MA
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