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EasyOne Sky Spirometer

by NDD Medizintechnik AG

510(k) K230178Ref 2800-1

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230178↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014219SpirometerBS Basic UDI-DI 07640142190554UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640142190554 UDI-DI Date21 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK230178 Date19 Oct 2023ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 764014219SpirometerBS registered 13 May 2026 Active
  • FDA 510(k) K230178 decided 19 Oct 2023 Active
  • FDA GUDID UDI-DI 07640142190554 listed 21 Apr 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230178
  2. Listed FDA GUDID 07640142190554
  3. Registered EUDAMED 764014219SpirometerBS

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
EasyOne Sky EUDAMED
EasyOne Sky Spirometer GUDID
Generic name
Diagnostic spirometer, professional
Device name
Spirometry Family
Model / reference
2800-1
Primary DI / UDI-DI
07640142190554
Basic UDI-DI
764014219SpirometerBS
Direct marketing DI
07640142190554
510(k) Number
FDA product code
BZG
EMDN code
Z12150180 Spirometry instruments - hardware accessories
GMDN term
Diagnostic spirometer, professional
Device class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 868.1840
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device classEUDAMED
Class IIa
510(k)
Class II
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 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EasyOne Sky Spirometer is a diagnostic device classified as a spirometer, designed to measure lung function parameters such as forced expiratory volume (FEV₁) and forced vital capacity (FVC). It provides objective data for assessing respiratory conditions, including obstructive and restrictive lung diseases, by evaluating airflow and volume during forced exhalation.

This portable, single-use device is intended for use in clinical and home settings, adhering to FDA 510(k) and MDR regulatory standards. Supplied in sterile packaging, it requires no additional sterilization and is compatible with standard medical environments. The device is classified under device class II and is authorized for use in anesthesia and pulmonary function testing, with registration number 8030978 under regulation 868.1840.

Devices cleared under K230178

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K230178
UDI-DISize and differences
EasyOne Sky Spirometer 2800-1
NDD Medizintechnik AG
2800-107640142190554 —On the market

Similar devices in this category

Other devices filed under SPIROMETRY INSTRUMENTS.

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Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)