Cleared Traditional

K853569 - MEDIPART CORRUGATED POLYETHYLENE & E.V....

K853569 is an FDA 510(k) clearance for MEDIPART CORRUGATED POLYETHYLENE & E.V...., manufactured by Medipart Jerry Alexander. The device is a Class 1 Anesthesiology device with product code BYX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K853569 · Medipart Jerry Alexander · Anesthesiology device
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Nov 1985
Decision
73d
Days
Class 1
Risk

K853569 is an FDA 510(k) clearance for the MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING. Classified as Tubing, Pressure And Accessories (product code BYX), Class I - General Controls.

Submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5860 - 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 Medipart Jerry Alexander devices

FDA 510(k) Submission Details - K853569

510(k) Number K853569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date November 07, 1985
Days to Decision 73 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 140d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

BYX Device Classification - Class 1, General Controls

Product Code BYX Tubing, Pressure And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5860
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYX Tubing, Pressure And Accessories

All 19
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K853569.
BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES
K935835 · Busse Hospital Disposables, Inc. · Jan 1994
FLEXTUBE, CONNECTING TUBING
K860877 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
OXYGEN CONNECTING TUBE
K830988 · Medovations, Inc. · May 1983
OHIO AIR ADAPTOR
K813234 · Timeter Instrument Corp. · Dec 1981
TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR
K811549 · Timeter Instrument Corp. · Jun 1981
TIMETER PRODUCED CHEMETRON (NCG) AIR
K811550 · Timeter Instrument Corp. · Jun 1981