Cleared Special

K080510 - VIP PULMONARY FUNCTION SYSTEM

K080510 is an FDA 510(k) clearance for VIP PULMONARY FUNCTION SYSTEM, 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 177-day FDA review.

K080510 · Viasys Healthcare GmbH · Anesthesiology device
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Aug 2008
Decision
177d
Days
Class 2
Risk

K080510 is an FDA 510(k) clearance for the VIP PULMONARY FUNCTION SYSTEM. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Viasys Healthcare GmbH (Hoechberg, DE). The FDA issued a Cleared decision on August 20, 2008 after a review of 177 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 - K080510

510(k) Number K080510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2008
Decision Date August 20, 2008
Days to Decision 177 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
37d slower than avg
Panel avg: 140d · This submission: 177d
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 K080510.
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K071753 · Viasys Healthcare GmbH · Aug 2007
MODIFICATION TO FLOWSCREEN
K062011 · Viasys Healthcare GmbH · May 2007