Skip to content

Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332A

by Applied Diabetes Research, Inc.

510(k) K041152

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK041152 Date24 May 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ThinSet Reservoir is a single-use, piston-style syringe consisting of a hollow barrel, plunger with o-ring, and male Luer lock fitting at the distal end. It functions as a reservoir for medication, including insulin, placed within an external infusion pump and includes a 22-gauge cannula.

The device is used in clinical or home settings to deliver subcutaneous medication. It is supplied as a single-use device and is available in 1.8 ml and 3.0 ml capacities. The device has FDA 510(k) clearance with product code FRN and is classified as a pump, infusion device.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ThinSet Reservoir used for?

    The ThinSet Reservoir is a single-use, piston-style syringe designed to function as a medication reservoir within external infusion pumps. It is used in clinical or home settings to deliver subcutaneous medications, including insulin, through a 22-gauge cannula.

  • What capacities are available for the ThinSet Reservoir?

    The ThinSet Reservoir is available in two capacities: 1.8 ml (Model 326A) and 3.0 ml (Model 332A). These different sizes allow for flexibility in medication delivery needs depending on the treatment requirements.

  • Is the ThinSet Reservoir reusable or single-use?

    The ThinSet Reservoir is supplied as a single-use device only. It should not be reused as this could compromise sterility and proper functioning of the device, potentially affecting medication delivery accuracy and patient safety.

  • What is the regulatory status of the ThinSet Reservoir?

    The ThinSet Reservoir has FDA 510(k) clearance with product code FRN and is classified as a pump, infusion device. It received clearance on May 24, 2004, and is substantially equivalent to other devices in this category.