510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220916Substantially Equivalent

iLet® Dosing Decision Software

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

K220916 is the FDA 510(k) clearance record for iLet® Dosing Decision Software, a class II device, cleared for Beta Bionics, Inc. on under FDA product code QJI (Interoperable Automated Glycemic Controller). FDA's definition for product code QJI reads: "An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a...". FDA records list 6 510(k) clearances for Beta Bionics, Inc., from to . As of , FDA records show no recalls naming K220916.

Clearance record

Decision date
Received
(415 days to decision)
Product code
QJI Interoperable Automated Glycemic Controller
Regulation
21 CFR 862.1356
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 QJI

Trailing 12 months
9 clearances under product code QJI in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QJI, trailing twelve months
MonthClearances
November 20250
December 20252
January 20261
February 20261
March 20260
April 20261
May 20260
June 20261
July 20261
August 20260
September 20262
October 20260