Cleared Traditional

K833088 - SPIROMETER ISOLATION VALVE #8890

K833088 is an FDA 510(k) clearance for SPIROMETER ISOLATION VALVE #8890, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K833088 · Boehringer Mannheim Corp. · Anesthesiology device
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Oct 1983
Decision
46d
Days
Class 1
Risk

K833088 is an FDA 510(k) clearance for the SPIROMETER ISOLATION VALVE #8890. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 46 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K833088

510(k) Number K833088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1983
Decision Date October 28, 1983
Days to Decision 46 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
94d faster than avg
Panel avg: 140d · This submission: 46d
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 43
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K833088.
ANESTHESIA VENTILATOR CIRCUIT
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PEDIATRIC INTUBATION CIRCUIT
K840056 · Ackrad Laboratories · Feb 1984
VOLUME VENTILATOR CIRCUIT-NEBULIZER
K833196 · Airlife, Inc. · Nov 1983
BRAIN MODULE RJ-Z10
K830475 · Instrumentation Industries, Inc. · Jun 1983
DISPOSABLE NON-REBREATHING ANES. CIRCUIT
K823714 · Marquest Medical Products, Inc. · Jan 1983
DISPOSABLE ANESTHESIA BREATHING CIRCUIT
K822379 · Marquest Medical Products, Inc. · Aug 1982