Cleared Traditional

K102377 - VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O

Also marketed or referenced as:
VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O VENTIPLUS DISPOSABLE MANOMETER 0

K102377 is an FDA 510(k) clearance for VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O, manufactured by A Plus Medical. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K102377 · A Plus Medical · Anesthesiology device
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Nov 2010
Decision
90d
Days
Class 2
Risk

K102377 is an FDA 510(k) clearance for the VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by A Plus Medical (Carlsbad, US). The FDA issued a Cleared decision on November 18, 2010 after a review of 90 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.

View all A Plus Medical devices

FDA 510(k) Submission Details - K102377

510(k) Number K102377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2010
Decision Date November 18, 2010
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 K102377.
VORTRAN Manometer
K153733 · Vortran Medical Technology 1, Inc. · Sep 2016
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