Cleared Traditional

K932561 - GUEDEL AIRWAYS

K932561 is an FDA 510(k) clearance for GUEDEL AIRWAYS, manufactured by Life Shield Healthcare Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K932561 · Life Shield Healthcare Products, Inc. · Anesthesiology device
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Jul 1993
Decision
56d
Days
Class 2
Risk

K932561 is an FDA 510(k) clearance for the GUEDEL AIRWAYS. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Life Shield Healthcare Products, Inc. (Noblesville, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Life Shield Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K932561

510(k) Number K932561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1993
Decision Date July 22, 1993
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 154
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K932561.
BIVONA(R) ICU ENDOTRACHEAL TUBE
K931749 · Bivona Medical Technologies · Aug 1993
RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE
K925506 · Rusch, Inc. · Aug 1993
PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS
K932711 · Precision Med Products, Ltd. · Jul 1993
RAE(R) II TRACHEAL TUBE
K932280 · Mallinckrodt Medical · Jul 1993
RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE
K931163 · Rusch, Inc. · Jun 1993
RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY
K931164 · Rusch, Inc. · Jun 1993