Cleared Traditional

K120635 - EASYONE PRO RESPIRATORY TESTING DEVICE

K120635 is an FDA 510(k) clearance for EASYONE PRO RESPIRATORY TESTING DEVICE, manufactured by Ndd Medizitechnik AG. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K120635 · Ndd Medizitechnik AG · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
210d
Days
Class 2
Risk

K120635 is an FDA 510(k) clearance for the EASYONE PRO RESPIRATORY TESTING DEVICE. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Ndd Medizitechnik AG (Andover, US). The FDA issued a Cleared decision on September 27, 2012 after a review of 210 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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.

FDA 510(k) Submission Details - K120635

510(k) Number K120635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2012
Decision Date September 27, 2012
Days to Decision 210 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 140d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 43
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K120635.
EasyOne Pro Respiratory Analysis System
K161534 · Ndd Medizintechnik AG · Feb 2017
Shape-HF Cardiopulmonary Testing System
K150888 · Shape Medical Systems, Inc. · Jan 2016
SENTRYSUITE PRODUCT LINE
K122699 · Carefusion Germany 234 GmbH · Nov 2012
SENTRYSUITE PRODUCT LINE
K113813 · Carefusion Germany 234 GmbH · May 2012
SENTRYSUITE PRODUCT LINE
K111053 · Carefusion Germany 234 GmbH · Aug 2011
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
K091428 · Ndd Medizitechnik AG · Jan 2010