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Care Touch CTCSW

by Future Diagnostics LLC

Care Touch CTCSW is a Class II device made by Future Diagnostics LLC, cleared under FDA 510(k) K131463 on 8 Jul 2013 and listed in FDA GUDID since 27 Sep 2016 (UDI-DI 00370393904019), 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) K131463

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 Number00370393904019 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131463 Date8 Jul 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131463 decided 8 Jul 2013 Active
  • FDA GUDID UDI-DI 00370393904019 listed 27 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131463
  2. Listed FDA GUDID 00370393904019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Care Touch
Generic name
Patient monitoring system module, blood pressure, noninvasive
Model / reference
CTCSW
Primary DI / UDI-DI
00370393904019
510(k) Number
FDA product code
DXN
GMDN term
Patient monitoring system module, blood pressure, noninvasive
Device class
Class II
Regulation number
870.1130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Patient monitoring system module, blood pressure, noninvasive

Cleared under the same submission (K131463)

and 3 more cleared under K131463

Similar devices in this category

Other devices filed under Patient monitoring system module, blood pressure, noninvasive.

Other devices from Future Diagnostics LLC

See all devices from Future Diagnostics LLC →

Properties

  • Supplied sterile
  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)