Skip to content

Threshold 00

by Respironics Respiratory Drug Delivery (UK) Ltd 5 variants

Threshold 00 (HS730-010) is a Class II device made by Respironics Respiratory Drug Delivery (UK) Ltd, listed in FDA GUDID since 24 Aug 2016 (UDI-DI 00383730001012), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00383730001012 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Threshold
Generic name
Incentive spirometer
Model / Ref / Catalog
00, HS730-010
Primary DI / UDI-DI
00383730001012
FDA product code
BWF
GMDN term
Incentive spirometer
Device class
Class II
Regulation number
868.5690
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code BWF (SPIROMETER, THERAPEUTIC (INCENTIVE)).

Other devices from Respironics Respiratory Drug Delivery (UK) Ltd

See all devices from Respironics Respiratory Drug Delivery (UK) Ltd →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)