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Heyvalue NASA603

by Oak Tech LLC 5 variants

Heyvalue NASA603 is a Class II device made by Oak Tech LLC, cleared under FDA 510(k) K244033 on 16 May 2025 and listed in FDA GUDID since 13 Oct 2025 (UDI-DI 00860014577550), 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) K244033

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 Number00860014577550 UDI-DI Date13 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK244033 Date16 May 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K244033 decided 16 May 2025 Active
  • FDA GUDID UDI-DI 00860014577550 listed 13 Oct 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K244033
  2. Listed FDA GUDID 00860014577550

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Heyvalue
Generic name
Nasal aspirator, electric
Model / reference
NASA603
Primary DI / UDI-DI
00860014577550
510(k) Number
FDA product code
BTA
GMDN term
Nasal aspirator, electric
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K244033)

and 4 more cleared under K244033

Similar devices

Other devices filed under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Other devices from Oak Tech LLC

  • Grownsy BC024

    Class II

  • Heyvalue NASA603

    Class II

  • Grownsy NASA610

    Class II

  • Grownsy NASA006

    Class II

See all devices from Oak Tech LLC →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)