Cleared Traditional

K040549 - COSMED PONY FX

K040549 is an FDA 510(k) clearance for COSMED PONY FX, manufactured by Cosmed Srl. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K040549 · Cosmed Srl · Anesthesiology device
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Sep 2004
Decision
210d
Days
Class 2
Risk

K040549 is an FDA 510(k) clearance for the COSMED PONY FX. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Cosmed Srl (West Cadwell, US). The FDA issued a Cleared decision on September 28, 2004 after a review of 210 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.

View all Cosmed Srl devices

FDA 510(k) Submission Details - K040549

510(k) Number K040549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2004
Decision Date September 28, 2004
Days to Decision 210 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 140d · This submission: 210d
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 40
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K040549.
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
K080734 · Viasys Healthcare GmbH · Jun 2008
MASTERSCREEN PNEUMO & MASTERSCOPE
K071753 · Viasys Healthcare GmbH · Aug 2007
MODIFICATION TO FLOWSCREEN
K062011 · Viasys Healthcare GmbH · May 2007
COSMED MICROQUARK
K020745 · Cosmed Srl · Jan 2003
METALYZER, MODEL 2
K993641 · Cortex Biophysik GmbH · Dec 2000
SPIRO PRO
K000648 · Erich Jaeger GmbH · Mar 2000