Cleared Traditional

K853487 - PATIENT BREATHING CIRCUIT

K853487 is an FDA 510(k) clearance for PATIENT BREATHING CIRCUIT, manufactured by Infrasonics Corp.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K853487 · Infrasonics Corp. · Anesthesiology device
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Sep 1985
Decision
17d
Days
Class 2
Risk

K853487 is an FDA 510(k) clearance for the PATIENT BREATHING CIRCUIT. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Infrasonics Corp. (San Diego, US). The FDA issued a Cleared decision on September 6, 1985 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Infrasonics Corp. devices

FDA 510(k) Submission Details - K853487

510(k) Number K853487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date September 06, 1985
Days to Decision 17 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
123d faster than avg
Panel avg: 140d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 316
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K853487.
FLOW GENERATOR FOR SLEEP APNEA, LDS 1500
K862448 · Life Design Systems, Inc. · Nov 1986
CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
K861555 · Respiratory Care, Inc. · Jun 1986
MEDICOMP CPAP NASAL CANNULA
K861280 · Medicomp, Inc. · May 1986
DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT)
K852821 · Puritan Bennett Corp. · Jul 1985
INFANT NASAL CANNULAE ASSEMBLY
K841773 · Ackrad Laboratories · Jul 1984
CPAP INFANT NASAL CANNULAE SET
K823936 · Ackrad Laboratories · Jan 1983