Cleared Traditional

K122627 - GIO DIGITAL PRESSURE GUAGES

K122627 is an FDA 510(k) clearance for GIO DIGITAL PRESSURE GUAGES, manufactured by Galemed Corp.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K122627 · Galemed Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
359d
Days
Class 2
Risk

K122627 is an FDA 510(k) clearance for the GIO DIGITAL PRESSURE GUAGES. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Galemed Corp. (Temecula, US). The FDA issued a Cleared decision on August 22, 2013 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K122627

510(k) Number K122627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2012
Decision Date August 22, 2013
Days to Decision 359 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
219d slower than avg
Panel avg: 140d · This submission: 359d
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 K122627.
VORTRAN Manometer
K153733 · Vortran Medical Technology 1, Inc. · Sep 2016
Disposable Pressure Manometer (DPM)
K143148 · Westmed, Inc. · Aug 2015
DISPOSABLE PRESSURE MANOMETER
K140370 · Besmed Health Business Corp · Jun 2014
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