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Dpm 313-5558

by Pulmodyne Inc.

Ref 313-5558

Dpm 313-5558 is a device classified as Class I in the EU and Class II in the US made by Pulmodyne Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-00841470111410), cleared under FDA 510(k) K003497 on 30 Nov 2000 and listed in FDA GUDID since 16 Mar 2018 (UDI-DI 00841470111410), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K003497

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841470111410 Basic UDI-DI 00841470111410UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841470111410 UDI-DI Date16 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK003497 Date30 Nov 2000DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00841470111410 registered 3 Nov 2026 Active
  • FDA 510(k) K003497 decided 30 Nov 2000 Active
  • FDA GUDID UDI-DI 00841470111410 listed 16 Mar 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K003497
  2. Listed FDA GUDID 00841470111410
  3. Registered EUDAMED B-00841470111410

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  • Withdrawn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
Dpm
Generic name
Airway pressure monitor, non-powered
Device name
Disposable Pressure Manometer
Model / reference
313-5558
Primary DI / UDI-DI
00841470111410
Basic UDI-DI
B-00841470111410
510(k) Number
FDA product code
CAP
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Airway pressure monitor, non-powered
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.2600
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Airway pressure monitor, non-powered

Cleared under the same submission (K003497)

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Pulmodyne Inc.

See all devices from Pulmodyne Inc. →

Properties

  • Single use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)