Cleared Special

K031194 - SPIROSOFT

K031194 is an FDA 510(k) clearance for SPIROSOFT, manufactured by Viasys Healthcare GmbH. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Special 510(k) pathway after a 105-day FDA review.

K031194 · Viasys Healthcare GmbH · Anesthesiology device
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Jul 2003
Decision
105d
Days
Class 2
Risk

K031194 is an FDA 510(k) clearance for the SPIROSOFT. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Viasys Healthcare GmbH (Yorba Linda, US). The FDA issued a Cleared decision on July 30, 2003 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031194

510(k) Number K031194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2003
Decision Date July 30, 2003
Days to Decision 105 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 140d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

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 K031194.
MASTERSCREEN PNEUMO & MASTERSCOPE
K071753 · Viasys Healthcare GmbH · Aug 2007
MODIFICATION TO FLOWSCREEN
K062011 · Viasys Healthcare GmbH · May 2007
COSMED PONY FX
K040549 · Cosmed Srl · Sep 2004
COSMED MICROQUARK
K020745 · Cosmed Srl · Jan 2003
METALYZER, MODEL 2
K993641 · Cortex Biophysik GmbH · Dec 2000
SPIRO PRO
K000648 · Erich Jaeger GmbH · Mar 2000