Cleared Traditional

K873359 - AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR C...

K873359 is an FDA 510(k) clearance for AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR C..., manufactured by American Pharmaseal Div. Ahsc. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K873359 · American Pharmaseal Div. Ahsc · Anesthesiology device
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Nov 1987
Decision
77d
Days
Class 1
Risk

K873359 is an FDA 510(k) clearance for the AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on November 6, 1987 after a review of 77 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K873359

510(k) Number K873359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1987
Decision Date November 06, 1987
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
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 48
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K873359.
ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP
K893919 · Baxter Healthcare Corp · Sep 1989
BIVONA VENTILATOR ISOLATOR SYSTEM
K890499 · Bivona Medical Technologies · Jun 1989
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
K881141 · Baxter Healthcare Corp · Apr 1988
BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE
K871669 · Life Design Systems, Inc. · May 1987
PENLON CIRCLE SYSTEM
K864588 · Bear Medical Systems, Inc. · Feb 1987
CIRCUIT ANES. BREATHING & COMPONENTS
K862003 · Vital Signs, Inc. · Jul 1986