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RESPeRATE ULTRA

by 2BREATHE Technologies Ltd

RESPeRATE ULTRA is a Class II device made by 2BREATHE Technologies Ltd, cleared under FDA 510(k) K020399 on 2 Jul 2002 and listed in FDA GUDID since 19 Nov 2017 (UDI-DI 07290017402000), 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) K020399

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 Number07290017402000 UDI-DI Date19 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020399 Date2 Jul 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020399 decided 2 Jul 2002 Active
  • FDA GUDID UDI-DI 07290017402000 listed 19 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020399
  2. Listed FDA GUDID 07290017402000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RESPeRATE
Generic name
Biofeedback system
Model / reference
ULTRA
Primary DI / UDI-DI
07290017402000
510(k) Number
FDA product code
HCC
GMDN term
Biofeedback system
Device class
Class II
Regulation number
882.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Biofeedback system

Cleared under the same submission (K020399)

Similar devices

Other devices filed under FDA product code HCC (Device, Biofeedback).

Other devices from 2BREATHE Technologies Ltd

  • RESPeRATE Deluxe

    Class II

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)