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- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- QFGAlternate Controller Enabled Insulin Infusion Pump2Product Code
- K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)2Cleared 510(K)
- K253074Tandem Mobi insulin pump with interoperable technology2Cleared 510(K)
- K252770iLet ACE Pump2Cleared 510(K)
- K250792t:slim X2 insulin pump with interoperable technology2Cleared 510(K)
- K251032MiniMed 780G insulin pump2Cleared 510(K)
- K250930twiist system2Cleared 510(K)
- K234027embecta Insulin Delivery System2Cleared 510(K)
- K241078Tandem Mobi Insulin Pump with interoperable technology2Cleared 510(K)
- K241178DEKA ACE Pump System2Cleared 510(K)
- K240309Tandem Mobi insulin pump with interoperable technology2Cleared 510(K)
Show All 25 Submissions
- LZFPump, Infusion, Analytical Sampling2Product Code
- LZGPump, Infusion, Insulin2Product Code
- Subpart F—Immunological Test SystemsCFR Sub-Part
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iLet ACE Pump
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K252770
- 510(k) Type
- Special
- Applicant
- Beta Bionics, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/29/2025
- Days to Decision
- 27 days
- Submission Type
- Summary