Cleared Special

K062011 - MODIFICATION TO FLOWSCREEN

K062011 is an FDA 510(k) clearance for MODIFICATION TO FLOWSCREEN, 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 298-day FDA review.

K062011 · Viasys Healthcare GmbH · Anesthesiology device
Download Printable Device Report (PDF)
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May 2007
Decision
298d
Days
Class 2
Risk

K062011 is an FDA 510(k) clearance for the MODIFICATION TO FLOWSCREEN. 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 May 11, 2007 after a review of 298 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. 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 - K062011

510(k) Number K062011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2006
Decision Date May 11, 2007
Days to Decision 298 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
158d slower than avg
Panel avg: 140d · This submission: 298d
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 K062011.
VIP PULMONARY FUNCTION SYSTEM
K080510 · Viasys Healthcare GmbH · Aug 2008
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
K080734 · Viasys Healthcare GmbH · Jun 2008
MASTERSCREEN PNEUMO & MASTERSCOPE
K071753 · Viasys Healthcare GmbH · Aug 2007
COSMED PONY FX
K040549 · Cosmed Srl · Sep 2004
SPIROSOFT
K031194 · Viasys Healthcare GmbH · Jul 2003
COSMED MICROQUARK
K020745 · Cosmed Srl · Jan 2003