510(k) Report

FDA applicant

Beta Bionics, Inc.

Concord, MA9 decisions2023–20263 recalls

FDA records 9 decisions for Beta Bionics, Inc. (Concord, MA) from 2023 to 2026: 9 510(k) clearances. Most are in product codes QFG (Alternate Controller Enabled Insulin Infusion…) and QJI (Interoperable Automated Glycemic Controller). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 5 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Beta Bionics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 42025: 12026 (partial year): 4
2023high 4 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2026

2025: 22026 (partial year): 1
2023high 2 (2025) · low 0 (2023)2026

Class I Class II/III not classified

FIG. 1 — Beta Bionics, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Beta Bionics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QFGAlternate Controller Enabled Insulin Infusion Pump6decisions
  • QJIInteroperable Automated Glycemic Controller3decisions

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 57 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 103 days; 5 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 5 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220916iLet® Dosing Decision SoftwareBeta Bionics, Inc. · 20231cites it
  • K223846iLet® ACE PumpBeta Bionics, Inc. · 20231cites it
  • K232224iLet® Dosing Decision SoftwareBeta Bionics, Inc. · 20231cites it
  • K231485iLet® ACE PumpBeta Bionics, Inc. · 20231cites it
  • K252770iLet ACE PumpBeta Bionics, Inc. · 20251cites it

What has FDA decided for it lately?

  • K263422Mint ACE PumpBeta Bionics, Inc. · 2026
  • K262763iLet Dosing Decision SoftwareBeta Bionics, Inc. · 2026
  • K260001Mint ACE PumpBeta Bionics, Inc. · 2026
  • K253976iLet ACE PumpBeta Bionics, Inc. · 2026
  • K252770iLet ACE PumpBeta Bionics, Inc. · 20252 recalls
  • K232224iLet® Dosing Decision SoftwareBeta Bionics, Inc. · 20231 recall
  • K231485iLet® ACE PumpBeta Bionics, Inc. · 20231 recall
  • K220916iLet® Dosing Decision SoftwareBeta Bionics, Inc. · 2023

All 9 as Beta Bionics, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K252770iLet Bionic Pancreas, REF: BB1001Mar 12, 2026Class II
  • K252770iLet Bionic Pancreas, REF: BB1001Sep 23, 2025Class II
  • K231485iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision SoftwareAug 13, 2025Class II

Other applicant names beginning “Beta”

FDA records each applicant name separately; these may or may not be the same firm.

Beta Medical Products Co. 3Beta Biomed Services, Inc. 2Beta Labs, Inc. 1Beta Med Pharmaceuticals, Inc. 1Beta Optical Co, Inc. 1Beta Toys, Inc. 1Beta Chemicals, Inc. 1Beta Healthcare Products Pvt., Ltd. 1