Cleared Traditional

K843036 - PATIENT BREATHING CIRCUIT

K843036 is an FDA 510(k) clearance for PATIENT BREATHING CIRCUIT, manufactured by Infrasonics Corp.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K843036 · Infrasonics Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
13d
Days
Class 1
Risk

K843036 is an FDA 510(k) clearance for the PATIENT BREATHING CIRCUIT. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Infrasonics Corp. (Mchenry, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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 - K843036

510(k) Number K843036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1984
Decision Date August 15, 1984
Days to Decision 13 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
127d faster than avg
Panel avg: 140d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
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 - BZO Set, Tubing And Support, Ventilator (w Harness)

All 52
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K843036.
DISPOSABLE VENTILATOR CIRCUITS
K860879 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
VENTILATOR CIRCUITS (VARIOUS TYPES)
K860880 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
SAF T FLO VENTILATOR TUBING
K850703 · Bivona Medical Technologies · Mar 1985
PATIENT TUBING HYTREL SIEMENS-ELEMA
K841657 · Siemens Elema AB · May 1984
MASS SPECTROMETER INTERFACE
K841722 · Dryden Corp. · May 1984
THREE PORT SENSOR MANIFOLD
K841637 · Dryden Corp. · May 1984