Skip to content

EasyOne Pro Respiratory Testing Device

by Ndd Medizitechnik AG

510(k) K120635

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120635 Date27 Sep 2012ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
BTY
Device class
Class II
Regulation
21 CFR Part 868.1890
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

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

Cited by

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

Overview

AI-generated summary, 19 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 Pro Respiratory Testing Device is a portable pulmonary function testing machine classified as a Calculator, Predicted Values, Pulmonary Function device under FDA regulation 868.1890. It performs spirometry, single-breath carbon monoxide diffusion (DLCO) testing, and multiple-breath nitrogen washout assessments to evaluate lung function parameters such as airflow, lung volumes, and gas exchange efficiency.

This device is intended for use in clinical settings, including general practice, clinics, and hospitals, and is designed for point-of-care diagnostics. Supplied as a reusable medical instrument, it requires proper calibration and maintenance to ensure accurate results. Authorized under FDA 510(k) clearance (K120635) with a traditional review process, it adheres to regulatory standards for respiratory diagnostic equipment. No specific sterility claims are stated, but standard infection control protocols apply for reusable devices.

Devices cleared under K120635

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 K120635
UDI-DISize and differences
EasyOne Pro LAB 3100-1
NDD Medizintechnik AG
3100-1 / 3100-107640142190370 —On the market

Similar devices

Other devices filed under FDA product code BTY (Calculator, Predicted Values, Pulmonary Function).

Other devices from Ndd Medizitechnik AG