Cleared Traditional

K091428 - EASYONE PRO RESPIRATORY ANALYSIS SYSTEM

K091428 is an FDA 510(k) clearance for EASYONE PRO RESPIRATORY ANALYSIS SYSTEM, 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 258-day FDA review.

K091428 · Ndd Medizitechnik AG · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
258d
Days
Class 2
Risk

K091428 is an FDA 510(k) clearance for the EASYONE PRO RESPIRATORY ANALYSIS SYSTEM. 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 January 27, 2010 after a review of 258 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 - K091428

510(k) Number K091428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2009
Decision Date January 27, 2010
Days to Decision 258 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
118d slower than avg
Panel avg: 140d · This submission: 258d
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 K091428.
EASYONE PRO RESPIRATORY TESTING DEVICE
K120635 · Ndd Medizitechnik AG · Sep 2012
SENTRYSUITE PRODUCT LINE
K113813 · Carefusion Germany 234 GmbH · May 2012
SENTRYSUITE PRODUCT LINE
K111053 · Carefusion Germany 234 GmbH · Aug 2011
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
K090722 · Shape Medical Systems, Inc. · Mar 2009
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
K082539 · Cardinal Health Germany 234 GmbH · Dec 2008
VIP PULMONARY FUNCTION SYSTEM
K080510 · Viasys Healthcare GmbH · Aug 2008