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CarePoint Precision 04-0001

by Allison Medical, Inc.

CarePoint Precision 04-0001 is a Class II device made by Allison Medical, Inc., cleared under FDA 510(k) K124037 on 12 Sep 2013 and listed in FDA GUDID since 29 Nov 2023 (UDI-DI 00786227040158), 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) K124037

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 Number00786227040158 UDI-DI Date29 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK124037 Date12 Sep 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K124037 decided 12 Sep 2013 Active
  • FDA GUDID UDI-DI 00786227040158 listed 29 Nov 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K124037
  2. Listed FDA GUDID 00786227040158

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CarePoint Precision
Generic name
General-purpose syringe, single-use
Model / reference
04-0001
Primary DI / UDI-DI
00786227040158
510(k) Number
FDA product code
FMF
GMDN term
General-purpose syringe, single-use
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 Milliliter

Related devices

Category: General-purpose syringe, single-use

Cleared under the same submission (K124037)

and 8 more cleared under K124037

Similar devices in this category

Other devices filed under General-purpose syringe, single-use.

Other devices from Allison Medical, Inc.

See all devices from Allison Medical, Inc. →

Properties

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