Cleared Traditional

K122721 - AG GUFFILL

K122721 is an FDA 510(k) clearance for AG GUFFILL, manufactured by Hospitech Respiration , Ltd.. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K122721 · Hospitech Respiration , Ltd. · Anesthesiology device
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May 2013
Decision
240d
Days
Class 2
Risk

K122721 is an FDA 510(k) clearance for the AG GUFFILL. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Hospitech Respiration , Ltd. (Binyamina, IL). The FDA issued a Cleared decision on May 3, 2013 after a review of 240 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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 Hospitech Respiration , Ltd. devices

FDA 510(k) Submission Details - K122721

510(k) Number K122721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2012
Decision Date May 03, 2013
Days to Decision 240 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
100d slower than avg
Panel avg: 140d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSK Device Classification - Class 2, Special Controls

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
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 - BSK Cuff, Tracheal Tube, Inflatable

All 19
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K122721.
VORTRAN Cuff Inflator (VCI)
K173914 · Vortran Medical Technology 1, Inc. · May 2018
IntelliCuff
K150893 · Hamilton Medical AG · Jan 2016
CUFF PILOT, SURE SEAL
K142103 · Teleflexmedical, Inc. · May 2015
PILOT TUBE REPAIR KIT
K113644 · Instrumentation Industries, Inc. · Jan 2012
PILOT TUBE REPAIR KIT
K973755 · Instrumentation Industries, Inc. · Dec 1997
RUSCH ENDOTEST CUFF PRESSURE MONITOR
K951046 · Rusch Intl. · Apr 1995