Cleared Traditional

K881429 - YANKAUER SUCTION INSTRU./LAYTEX GLOVES/...

K881429 is the FDA 510(k) clearance for YANKAUER SUCTION INSTRU./LAYTEX GLOVES/... by Medical Repackers Co.. It is a Class 2 Anesthesiology device (product code CAZ) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

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
113d faster than avg
Panel avg: 140d · 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.

Regulatory Peers - CAZ Anesthesia Conduction Kit

All 38
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K881429.
INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.
K891281 · Arrow Intl., Inc. · Jul 1989
CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
K884552 · Arrow Intl., Inc. · Mar 1989
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
K882394 · Medtronic Vascular · Sep 1988
AXILLARY BLOCK NEEDLE
K880970 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1988
BRACHIAL PLEXUS CATHETER - BP-01200
K874105 · Arrow Intl., Inc. · Nov 1987
CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS
K873943 · Arrow Intl., Inc. · Oct 1987