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Spiro 707

by Fogless International AB

Ref 740-25K, 711-1K, 703-2K, 710-1KModel 740, 711, 703, 710

Spiro 707 (707-10) is a device classified as Class IIa and Class I in the EU and Class II in the US made by Fogless International AB, registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI B-27350061230173), cleared under FDA 510(k) K122932 on 23 Dec 2013 and listed in FDA GUDID since 31 Mar 2018 (UDI-DI 27350061230173), active as of 25 Oct 2026.

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

CE MDR 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122932

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-27350061230173 Basic UDI-DI Date10 Jun 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED NumberB-27350061230173 Basic UDI-DI Date10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number27350061230173 UDI-DI Date31 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122932 Date23 Dec 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-27350061230173 registered 10 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K122932 decided 23 Dec 2013 Active
  • FDA GUDID UDI-DI 27350061230173 listed 31 Mar 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122932
  2. Listed FDA GUDID 27350061230173
  3. Registered EUDAMED B-27350061230173

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Spiro
Generic name
Tracheostomy tube speech valve
Device name
Filter
Speaking Valve
Shower Protector for Humidifier
Speaking Valve with oxygen nipple
Model / Ref / Catalog
740 EUDAMED
740-25K EUDAMED
711 EUDAMED
711-1K EUDAMED
703 EUDAMED
703-2K EUDAMED
710 EUDAMED
710-1K EUDAMED
707 GUDID
707-10 GUDID
Primary DI / UDI-DI
27350061230173 EUDAMED
27350061230135 EUDAMED
47350061230221 EUDAMED
27350061230074 EUDAMED
27350061230227 EUDAMED
47350061230139 EUDAMED
47350061230078 EUDAMED
47350061230177 EUDAMED
07350061231084 GUDID
Basic UDI-DI
B-27350061230173, 73500612300677, 7350061230026X, B-27350061230074, B-47350061230078, B-47350061230177
Unit of use DI
07350061231305
510(k) Number
FDA product code
JOH
EMDN code
R040201, R900680, R90060202
GMDN term
Tracheostomy tube speech valve
Device class
Class IIa EUDAMED
Class I EUDAMED
Class II GUDID
Regulation number
868.5800
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Sweden
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
740
740-25K
711
711-1K
703
703-2K
710
710-1K
GUDID
707
Primary DI / UDI-DIEUDAMED
27350061230173
27350061230135
47350061230221
27350061230074
27350061230227
47350061230139
47350061230078
47350061230177
GUDID
07350061231084
Device classEUDAMED
Class IIa
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 27350061230173, 27350061230135, 47350061230221, 27350061230074, 27350061230227; FDA GUDID lists 07350061231084), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa and Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Related devices

Category: Tracheostomy tube speech valve

Cleared under the same submission (K122932)

and 3 more cleared under K122932

Similar devices in this category

Other devices filed under PHONATION VALVES FOR TRACHEOSTOMY.

Other devices from Fogless International AB

See all devices from Fogless International AB →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)