Cleared Traditional

K050309 - PULMANEX DISPOSABLE PRESSURE MANOMETER

K050309 is an FDA 510(k) clearance for PULMANEX DISPOSABLE PRESSURE MANOMETER, manufactured by Viasys Medsystems. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K050309 · Viasys Medsystems · Anesthesiology device
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Mar 2005
Decision
45d
Days
Class 2
Risk

K050309 is an FDA 510(k) clearance for the PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Viasys Medsystems (Wheeling, US). The FDA issued a Cleared decision on March 25, 2005 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Viasys Medsystems devices

FDA 510(k) Submission Details - K050309

510(k) Number K050309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2005
Decision Date March 25, 2005
Days to Decision 45 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
95d faster than avg
Panel avg: 140d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAP Device Classification - Class 2, Special Controls

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
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 - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 40
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K050309.
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
K120118 · Ventlab Corp. · May 2012
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
K103639 · Vortran Medical Technology 1, Inc. · Sep 2011
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
K081778 · Instrumentation Industries, Inc. · Sep 2008
AMBU DISPOSABLE PRESSURE MANOMETER
K040991 · Ambu, Inc. · Jul 2004
DISPOSABLE PRESSURE MANOMETER
K022402 · Vital Signs, Inc. · Aug 2002
DISPOSABLE PRESSURE MONITOR
K003497 · Engineered Medical Systems · Nov 2000