Cleared Traditional

K871386 - BREATHING CIRCUIT

K871386 is the FDA 510(k) clearance for BREATHING CIRCUIT by Dryden Corp.. It is a Class 1 Anesthesiology device (product code CAI) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K871386 · Dryden Corp. · Anesthesiology device
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May 1987
Decision
52d
Days
Class 1
Risk

K871386 is an FDA 510(k) clearance for the BREATHING CIRCUIT. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Dryden Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 29, 1987 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 Dryden Corp. devices

Submission Details

510(k) Number K871386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1987
Decision Date May 29, 1987
Days to Decision 52 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 140d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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 - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 25
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K871386.
BABYFLEX HEATED INFANT BREATHING CIRCUIT
K896365 · Baxter Healthcare Corp · Jan 1990
ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP
K893919 · Baxter Healthcare Corp · Sep 1989
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
K881141 · Baxter Healthcare Corp · Apr 1988
CIRCUIT ANES. BREATHING & COMPONENTS
K862003 · Vital Signs, Inc. · Jul 1986
CIRCUIT, ANES. BREATHING (NON-REBREATHING)
K861438 · Vital Signs, Inc. · May 1986
VOLUME VENTILATOR CIRCUIT-NEBULIZER
K833196 · Airlife, Inc. · Nov 1983