CarePoint Precision 505-3131

by Allison Medical, Inc.

CarePoint Precision 505-3131 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 00786227053752), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00786227053752 UDI-DI	Date29 Nov 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK124037	Date12 Sep 2013Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00786227053752
FDA 510(k) database 510(k) number K124037

Across registries

2 registries list this device

FDA 510(k) K124037 decided 12 Sep 2013 Active
FDA GUDID UDI-DI 00786227053752 listed 29 Nov 2023 Listed

Timeline

2 dated events

12 Sep 2013 Cleared FDA 510(k) K124037
29 Nov 2023 Listed FDA GUDID 00786227053752

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: CarePoint Precision
Generic name: General-purpose syringe/needle
Model / reference: 505-3131

Primary DI / UDI-DI: 00786227053752
510(k) Number: K124037
FDA product code: FMI, FMF
GMDN term: General-purpose syringe/needle

Device class: Class II
Regulation number: 880.5570, 880.5860
GUDID distribution status: In Commercial Distribution

Size: Needle Gauge — 23 Gauge
Length — 1 Inch
Total Volume — 3 Milliliter

Similar devices in this category

Other devices filed under General-purpose syringe/needle.

Other devices from Allison Medical, Inc.

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)