510(k) clearances

Mint ACE Pump

Beta Bionics, Inc. · Clinical Chemistry

K263422Substantially EquivalentSpecialQFG
Open FDA's page for this record
Third party flag
N
City
Irvine
Advisory committee description
Clinical Chemistry
Address 1
11 Hughes
Statement or summary
Summary
Product code
QFG
Zip code
92618
Applicant
Beta Bionics, Inc.
Decision date
2026-10-21
Decision code
SESE
Country code
US
Device name
Mint ACE Pump
Advisory committee
CH
Contact
Liz Cooper
K number
K263422
State
CA
Date received
2026-09-25
Review advisory committee
CH
Postal code
92618
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Alternate Controller Enabled Insulin Infusion Pump
Medical specialty description
Clinical Chemistry
Regulation number
880.5730
Device class
2
Registration number
3042027705, 3030970576, 1220477, 3013756811, 3008824097, 3016540876, 3007981285, 3005627859, 3019004087, 2029275, 2030598, 3047799708, 3016245399, 2246552, 3026266833, 3019807891, 2022435, 2032098, 3010291427, 3014585508, 2030624, 2032227, 2024024, 3014197758, 3044561902, 3016798778, 3015192982, 3032746481, 1220973
FEI number
3042027705, 3030970576, 1220477, 3013756811, 1000518731, 3008824097, 3016540876, 3000206435, 3007981285, 3005627859, 3019004087, 3047799708, 1000306431, 3016245399, 2246552, 3003058448, 3026266833, 3019807891, 2022435, 3003166194, 3010291427, 3014585508, 2024024, 3014197758, 3044561902, 3016798778, 3015192982, 3032746481, 1220973
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.