Cleared Traditional

K161536 - EasyOne Air Spirometer

K161536 is an FDA 510(k) clearance for EasyOne Air Spirometer, manufactured by Ndd Medizintechnik AG. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K161536 · Ndd Medizintechnik AG · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
216d
Days
Class 2
Risk

K161536 is an FDA 510(k) clearance for the EasyOne Air Spirometer. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Ndd Medizintechnik AG (Zurich, CH). The FDA issued a Cleared decision on January 5, 2017 after a review of 216 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ndd Medizintechnik AG devices

FDA 510(k) Submission Details - K161536

510(k) Number K161536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2016
Decision Date January 05, 2017
Days to Decision 216 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 140d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZG Spirometer, Diagnostic

All 50
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K161536.
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
K191013 · Welch Allyn, Inc. · Sep 2019
ComPAS2 (Computerized Pulmonary Analysis System)
K190568 · Morgan Scientific, Inc. · Jun 2019
Pulmonx Chartis Tablet Console
K180011 · Pulmonx Corporation · Jul 2018
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
K082478 · Welch Allyn, Inc. · Mar 2009
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
K052158 · Welch Allyn, Inc. · Sep 2005
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
K023225 · Puritan Bennett Corp. · Dec 2002