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PADnet 2.0

by Collaborative Care Diagnostics LLC

PADnet 2.0 is a Class II device made by Collaborative Care Diagnostics LLC, cleared under FDA 510(k) K122281 on 29 Aug 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00862467000302), 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

510(k) K122281

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00862467000302 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122281 Date29 Aug 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122281 decided 29 Aug 2012 Active
  • FDA GUDID UDI-DI 00862467000302 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122281
  2. Listed FDA GUDID 00862467000302

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PADnet
Generic name
Limb plethysmograph
Model / reference
2.0
Primary DI / UDI-DI
00862467000302
510(k) Number
FDA product code
JOM
GMDN term
Limb plethysmograph
Device class
Class II
Regulation number
870.2780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Limb plethysmograph

Similar devices

Other devices filed under FDA product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic).

Other devices from Collaborative Care Diagnostics LLC

Properties

  • Serial number
Other properties (14, all answered No)