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Nebulizer Kit RES091DS

by Sunset Healthcare Solutions

Nebulizer Kit RES091DS is a nebulizing system delivery set (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Sunset Healthcare Solutions, cleared under FDA 510(k) K182906 on 27 Sep 2020 (1 earlier submission) and listed in FDA GUDID since 21 May 2025 (UDI-DI 00848530096137), active as of 8 Nov 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848530096137 UDI-DI Date21 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK182906 Date27 Sep 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182906 decided 27 Sep 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00848530096137 listed 21 May 2025 Listed

Recalls

1 recall · FDA

    • Terminated Z-1058-2019 FDA Class II initiated 29 Aug 2018

    The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.

Timeline

4 dated events

  1. Cleared FDA 510(k) K091272
  2. Recall initiated FDA recalls Z-1058-2019
  3. Cleared FDA 510(k) K182906
  4. Listed FDA GUDID 00848530096137

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nebulizer Kit
Generic name
Nebulizing system delivery set, reusable
Model / reference
RES091DS
Primary DI / UDI-DI
00848530096137
510(k) Number
FDA product code
CAF
GMDN term
Nebulizing system delivery set, reusable
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: Nebulizer Kits

Related devices

Category: Nebulizing system delivery set, reusable

Cleared under the same submission (K091272)

and 8 more cleared under K091272

Cleared under the same submission (K182906)

and 3 more cleared under K182906

Similar devices

Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).

Other devices from Sunset Healthcare Solutions

See all devices from Sunset Healthcare Solutions →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)