Cleared Special

K071753 - MASTERSCREEN PNEUMO & MASTERSCOPE

K071753 is an FDA 510(k) clearance for MASTERSCREEN PNEUMO & MASTERSCOPE, 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 47-day FDA review.

K071753 · Viasys Healthcare GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
47d
Days
Class 2
Risk

K071753 is an FDA 510(k) clearance for the MASTERSCREEN PNEUMO & MASTERSCOPE. 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 August 14, 2007 after a review of 47 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K071753

510(k) Number K071753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2007
Decision Date August 14, 2007
Days to Decision 47 days
Submission Type Special
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
93d faster than avg
Panel avg: 140d · This submission: 47d
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 K071753.
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
K082539 · Cardinal Health Germany 234 GmbH · Dec 2008
VIP PULMONARY FUNCTION SYSTEM
K080510 · Viasys Healthcare GmbH · Aug 2008
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
K080734 · Viasys Healthcare GmbH · Jun 2008
MODIFICATION TO FLOWSCREEN
K062011 · Viasys Healthcare GmbH · May 2007
COSMED PONY FX
K040549 · Cosmed Srl · Sep 2004
SPIROSOFT
K031194 · Viasys Healthcare GmbH · Jul 2003