Cleared Traditional

K933762 - STB YANKAUER SUCKER/NOZZLE

K933762 is an FDA 510(k) clearance for STB YANKAUER SUCKER/NOZZLE, manufactured by Save-T-Breath Distributors C.C.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K933762 · Save-T-Breath Distributors C.C. · General Hospital
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Jul 1994
Decision
350d
Days
Class 2
Risk

K933762 is an FDA 510(k) clearance for the STB YANKAUER SUCKER/NOZZLE. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Save-T-Breath Distributors C.C. (South Africa, ZA). The FDA issued a Cleared decision on July 19, 1994 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Save-T-Breath Distributors C.C. devices

FDA 510(k) Submission Details - K933762

510(k) Number K933762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1993
Decision Date July 19, 1994
Days to Decision 350 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 129d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOL Device Classification - Class 2, Special Controls

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - JOL Catheter And Tip, Suction

All 50
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K933762.
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STERILE WATER FOR IRRATION
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DISPOSABLE SUCTION PROBE
K942061 · United States Surgical, A Division of Tyco Healthc · May 1994
THORA-CATH
K941232 · Gesco Intl., Inc. · May 1994
STERILE WATER
K933526 · Trinity Laboratories, Inc. · Mar 1994