BETA BIONICS, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3019004087

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019004087
FEI Number
3019004087
Entity Name
BETA BIONICS, INC.
City/State/Country
Irvine, CA, US
Establishment Address
11 Hughes, Irvine, CA 92618, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Beta Bionics, Inc. (Owner Number: 10088071)
Owner / Operator Contact Address
11 Hughes, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K021475
PMA Number
N/A

All Registered Proprietary Names

iLet Bionic Pancreas: iLet ACE Pump; iLet Charger; iLet Case, iLet Clip iLet Cartridge Kit iLet Connect Adapter iLet Insulin Infusion Kit - Contact Detach iLet Cartridge Kit iLet Insulin Infusion Kit – Contact Detach (23", 6mm) iLet Insulin Infusion Kit – Inset (23", 6mm) iLet Insulin Infusion Kit – Inset (32", 6mm) Bionic Circle App, iOS Bionic Circle App, Android iLet Insulin Infusion Kit - Flex (23", 6mm) iLet Insulin Infusion Kit - Flex (32", 6mm) iLet Cartridge Kit iLet Insulin Infusion Kit – Inset (32", 6mm) iLet Insulin Infusion Kit – Inset (23", 6mm) iLet Insulin Infusion Kit – Contact Detach (23", 6mm)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QFG Alternate Controller Enabled Insulin Infusion Pump Clinical Chemistry Class 2 880.5730 2023-05-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-05-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-05-23
PKU Insulin Pump Secondary Display Clinical Chemistry Class 2 862.1350 2024-11-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-03-09
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-05-23
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-05-23
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-05-23

Official Correspondent

Neal Grant

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Beta Bionics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019004087. Last updated year: 2026. Please use registration number 3019004087 when referencing this establishment in official correspondence.
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