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Simplicity QD Soft Infusion Set

by Sterling Medivations, Inc.

510(k) K013104

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 · Abbreviated NumberK013104 Date2 Oct 2001ClearedStatusActive

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  • Withdrawn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)

Full name
Simplicity Qd Soft Infusion Set for Use by People with Diabetes in Infuse Insulin Subcutaneously From a Pump or Syringe
510(k) Number
FDA Product Code
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Simplicity QD Soft Infusion Set is a medical device designed to provide a means to infuse insulin subcutaneously. It is intended for use by people with diabetes to deliver insulin from a pump or syringe into the subcutaneous space.

This device is authorized under FDA 510K clearance. It is designed for use in continuous subcutaneous insulin infusion therapy.

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