Cleared Traditional

K890499 - BIVONA VENTILATOR ISOLATOR SYSTEM

K890499 is an FDA 510(k) clearance for BIVONA VENTILATOR ISOLATOR SYSTEM, manufactured by Bivona Medical Technologies. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K890499 · Bivona Medical Technologies · Anesthesiology device
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Jun 1989
Decision
134d
Days
Class 1
Risk

K890499 is an FDA 510(k) clearance for the BIVONA VENTILATOR ISOLATOR SYSTEM. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on June 15, 1989 after a review of 134 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bivona Medical Technologies devices

FDA 510(k) Submission Details - K890499

510(k) Number K890499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1989
Decision Date June 15, 1989
Days to Decision 134 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
6d faster than avg
Panel avg: 140d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

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 116
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K890499.
VENTLAB ANESTHESIA CIRCUIT AC 6000
K896897 · Ventlab Corp. · Jan 1990
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
KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT
K880683 · King Systems Corp. · Mar 1988
AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE
K873359 · American Pharmaseal Div. Ahsc · Nov 1987