Cleared Traditional

K932711 - PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS

K932711 is an FDA 510(k) clearance for PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS, manufactured by Precision Med Products, Ltd.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K932711 · Precision Med Products, Ltd. · Anesthesiology device
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Jul 1993
Decision
49d
Days
Class 2
Risk

K932711 is an FDA 510(k) clearance for the PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Precision Med Products, Ltd. (Marrtinsville, US). The FDA issued a Cleared decision on July 23, 1993 after a review of 49 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 Precision Med Products, Ltd. devices

FDA 510(k) Submission Details - K932711

510(k) Number K932711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1993
Decision Date July 23, 1993
Days to Decision 49 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
91d faster than avg
Panel avg: 140d · This submission: 49d
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 K932711.
RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP
K925508 · Rusch, Inc. · Sep 1993
BIVONA(R) ICU ENDOTRACHEAL TUBE
K931749 · Bivona Medical Technologies · Aug 1993
RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE
K925506 · Rusch, Inc. · Aug 1993
GUEDEL AIRWAYS
K932561 · Life Shield Healthcare Products, Inc. · 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