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Schuco S5000

by Allied Medical LLC

Schuco S5000 is a nebulizing system delivery set (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Allied Medical LLC, cleared under FDA 510(k) K043238 on 6 Jul 2005 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00026072011683), 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) K043238

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 Number00026072011683 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK043238 Date6 Jul 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K043238 decided 6 Jul 2005 Active
  • FDA GUDID UDI-DI 00026072011683 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K043238
  2. Listed FDA GUDID 00026072011683

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Schuco
Generic name
Nebulizing system delivery set, reusable
Model / Ref / Catalog
S5000
Primary DI / UDI-DI
00026072011683
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

Related devices

Category: Nebulizing system delivery set, reusable

Cleared under the same submission (K043238)

and 8 more cleared under K043238

Similar devices

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

Other devices from Allied Medical LLC

See all devices from Allied Medical LLC →

Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)