Cleared Traditional

K881429 - YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH. (FDA 510(k) Clearance)

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

K881429 · Medical Repackers Co. · Anesthesiology device
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Apr 1988
Decision
27d
Days
Class 2
Risk

K881429 is an FDA 510(k) clearance for the YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Medical Repackers Co. (Fort Payne, US). The FDA issued a Cleared decision on April 25, 1988 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5140 - 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 Medical Repackers Co. devices

Submission Details

510(k) Number K881429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1988
Decision Date April 25, 1988
Days to Decision 27 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 139d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAZ Anesthesia Conduction Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5140
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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.