Cleared Traditional

K110119 - PRESSURE MANOMETER

K110119 is an FDA 510(k) clearance for PRESSURE MANOMETER, manufactured by Neoforce Group, Inc.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K110119 · Neoforce Group, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
143d
Days
Class 2
Risk

K110119 is an FDA 510(k) clearance for the PRESSURE MANOMETER. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Neoforce Group, Inc. (Ivyland, US). The FDA issued a Cleared decision on June 10, 2011 after a review of 143 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K110119

510(k) Number K110119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2011
Decision Date June 10, 2011
Days to Decision 143 days
Submission Type Traditional
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
3d slower than avg
Panel avg: 140d · This submission: 143d
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 56
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K110119.
MANOMETER
K122077 · Intersurgical, Inc. · Jan 2013
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
VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O
K102377 · A Plus Medical · Nov 2010
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
K081778 · Instrumentation Industries, Inc. · Sep 2008
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
K050309 · Viasys Medsystems · Mar 2005