Skip to content

VixOne™ 0210

by SunMed

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) K800562

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889483223949 UDI-DI Date19 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK800562 Date25 Mar 1980DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VixOne™
Generic name
Nebulizing system delivery set, single-use
Model / Ref / Catalog
0210
Primary DI / UDI-DI
10889483223949
510(k) Number
FDA product code
CAF
GMDN term
Nebulizing system delivery set, single-use
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K800562)

Show all (12)

Other devices from SunMed

See all devices from SunMed →

Properties

  • Single use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No