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Bleep Halos 100590

by Bleep, LLC

Bleep Halos 100590 is a Class II device made by Bleep, LLC, cleared under FDA 510(k) K172335 on 30 Mar 2018 and listed in FDA GUDID since 23 Aug 2022 (UDI-DI 00850003157115), 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) K172335

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 Number00850003157115 UDI-DI Date23 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172335 Date30 Mar 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172335 decided 30 Mar 2018 Active
  • FDA GUDID UDI-DI 00850003157115 listed 23 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172335
  2. Listed FDA GUDID 00850003157115

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bleep Halos
Generic name
Home CPAP unit
Model / reference
100590
Primary DI / UDI-DI
00850003157115
510(k) Number
FDA product code
BZD
GMDN term
Home CPAP unit
Device class
Class II
Regulation number
868.5905
GUDID distribution status
In Commercial Distribution

Related devices

Category: Home CPAP unit

Cleared under the same submission (K172335)

and 8 more cleared under K172335

Similar devices

Other devices filed under FDA product code BZD (Ventilator, Non-Continuous (Respirator)).

Other devices from Bleep, LLC

See all devices from Bleep, LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)