Skip to content

CoughAssist

by Respironics Inc. 8 variants

Ref 1090831

CoughAssist (1090831) is a device classified as Class IIa in the EU and Class II in the US made by Respironics Inc., registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI B-00606959021204), cleared under FDA 510(k) K121955 on 14 Dec 2012 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00606959021204), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121955

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00606959021204 Basic UDI-DI 00606959021204UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00606959021204 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121955 Date14 Dec 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00606959021204 registered 21 Jul 2026 Active
  • FDA 510(k) K121955 decided 14 Dec 2012 Active
  • FDA GUDID UDI-DI 00606959021204 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K121955
  2. Listed FDA GUDID 00606959021204
  3. Registered EUDAMED B-00606959021204

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
CoughAssist 70 Series Circuit, Toddler, 6ft EUDAMED
CoughAssist GUDID
Generic name
Positive pressure airway secretion-clearing device
Model / Ref / Catalog
1090831, CoughAssist 70 Series Circuit, Toddler, 6ft
Primary DI / UDI-DI
00606959021204
Basic UDI-DI
B-00606959021204
510(k) Number
FDA product code
NHJ
EMDN code
R05010301 Single-chamber mucous membrane aspirators
GMDN term
Positive pressure airway secretion-clearing device
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5905
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1090831
GUDID
CoughAssist 70 Series Circuit, Toddler, 6ft
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Positive pressure airway secretion-clearing device

Cleared under the same submission (K121955)

and 8 more cleared under K121955

Similar devices in this category

Other devices filed under SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS.

Other devices from Respironics Inc.

See all devices from Respironics Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)