Fora Xl

by Fora Care Inc.

Fora Xl is a Class II device made by Fora Care Inc., cleared under FDA 510(k) K152468 on 29 Oct 2015 and listed in FDA GUDID since 26 Oct 2023 (UDI-DI 00816042014871), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00816042014871 UDI-DI	Date26 Oct 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK152468	Date29 Oct 2015Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00816042014871
FDA 510(k) database 510(k) number K152468

Across registries

2 registries list this device

FDA 510(k) K152468 decided 29 Oct 2015 Active
FDA GUDID UDI-DI 00816042014871 listed 26 Oct 2023 Listed

Timeline

2 dated events

29 Oct 2015 Cleared FDA 510(k) K152468
26 Oct 2023 Listed FDA GUDID 00816042014871

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Fora
Generic name: Blood pressure cuff, reusable
Model / reference: XL

Primary DI / UDI-DI: 00816042014871
510(k) Number: K152468
FDA product code: DXN
GMDN term: Blood pressure cuff, reusable

Device class: Class II
Regulation number: 870.1130
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Blood pressure cuff, reusable.

Other devices from Fora Care Inc.

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Fora 30g

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FORA Test N'GO Advance Pro

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FORA Small Size

Class II

See all devices from Fora Care Inc. →

Properties

Lot / batch number
Manufacturing date

Other properties (13, all answered No)