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Novolinpen Dial-A-Dose Insulin Delivery System

by Squibb-Novo, Inc.

510(k) K872805

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 · Traditional NumberK872805 Date9 Oct 1987ClearedStatusActive

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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Novolinpen Dial-A-Dose Insulin Delivery System is a piston syringe designed for the administration of insulin. It functions as a delivery system to facilitate the precise dosing of medication.

This device is identified under FDA 510(k) number K872805 and is classified as a Class 2 medical device. It is categorized under the General Hospital medical specialty and received traditional clearance on October 9, 1987.

Other devices from Squibb-Novo, Inc.

Questions

AI-generated answers, 23 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 primary function of the Novolinpen Dial-A-Dose?

    The Novolinpen Dial-A-Dose is a piston syringe system engineered to facilitate the precise dosing and administration of insulin for patients requiring medication delivery.

  • What is the regulatory status of this device?

    The Novolinpen Dial-A-Dose is a Class 2 medical device that received traditional FDA 510(k) clearance on October 9, 1987, under the submission number K872805.

  • Which medical specialty is this device associated with?

    This device is categorized under the General Hospital medical specialty, as indicated by the advisory committee classification HO used during the regulatory filing process.