Cleared Traditional

K830922 - TEMP-CHECK ADAPTOR, TEE-CONFIGURATION

K830922 is an FDA 510(k) clearance for TEMP-CHECK ADAPTOR, manufactured by Cygnus Research Corp.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K830922 · Cygnus Research Corp. · Anesthesiology device
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May 1983
Decision
41d
Days
Class 1
Risk

K830922 is an FDA 510(k) clearance for the TEMP-CHECK ADAPTOR, TEE-CONFIGURATION. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Cygnus Research Corp. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1983 after a review of 41 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.

FDA 510(k) Submission Details - K830922

510(k) Number K830922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1983
Decision Date May 02, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
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 61
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K830922.
THREE PORT SENSOR MANIFOLD
K841637 · Dryden Corp. · May 1984
VOLUME VENTILATOR CIRCUIT W/WATER TRAP
K834570 · Airlife, Inc. · Mar 1984
UNIVERSAL VOL. VENTILATOR 72 #1626
K832681 · Hudson Oxygen Therapy Sales Co. · Sep 1983
DISPOSABLE ADULT VO. VENTILATOR CIRCUIT
K823271 · Intec Medical, Inc. · Dec 1982
BE #16 - MANIFOLD
K823481 · Instrumentation Industries, Inc. · Dec 1982
MODUFLEX NEONATAL VENTILATOR SET
K823479 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1982
K830922 · TEMP-CHECK ADAPTOR, TEE-CONFIGURATION
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