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Sure Comfort 22-8010

by Allison Medical, Inc.

Sure Comfort 22-8010 is a Class II device made by Allison Medical, Inc., cleared under FDA 510(k) K152879 on 9 Sep 2016 and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00786227801056), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K152879

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00786227801056 UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152879 Date9 Sep 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152879 decided 9 Sep 2016 Active
  • FDA GUDID UDI-DI 00786227801056 listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152879
  2. Listed FDA GUDID 00786227801056

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sure Comfort
Generic name
Insulin syringe/needle, basic
Model / Ref / Catalog
22-8010
Primary DI / UDI-DI
00786227801056
510(k) Number
FDA product code
FMF
GMDN term
Insulin syringe/needle, basic
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 Milliliter
Length — 12.7 Millimeter
Needle Gauge — 28 Gauge

Related devices

Category: Insulin syringe/needle, basic

Cleared under the same submission (K152879)

and 8 more cleared under K152879

Similar devices

Other devices filed under FDA product code FMF (Syringe, Piston).

Other devices from Allison Medical, Inc.

See all devices from Allison Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)