Cleared Traditional

AG GUFFILL (K122721) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 12
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K122721.
Accucuff Cuff Pressure Indicator
K182548 · Tianjin Medis Medical Device Co., Ltd. · Jan 2019
AG 100s
K180991 · Hospitech Respiration , Ltd. · Oct 2018
VORTRAN Cuff Inflator (VCI)
K173914 · Vortran Medical Technology 1, Inc. · May 2018
RESPIRONICS PR VALVE
K833327 · Respironics, Inc. · Nov 1983
SHILEY PRESSURE RELIEF ADAPTER PRA
K792265 · Shiley, Inc. · Nov 1979