Cleared Traditional

K884090 - LUNDY VAPORIZER SYSTEM

K884090 is an FDA 510(k) clearance for LUNDY VAPORIZER SYSTEM, manufactured by Vaporflow Technology, Inc.. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K884090 · Vaporflow Technology, Inc. · Anesthesiology device
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Jan 1989
Decision
118d
Days
Class 2
Risk

K884090 is an FDA 510(k) clearance for the LUNDY VAPORIZER SYSTEM. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Vaporflow Technology, Inc. (Tustin, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5880 - 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.

FDA 510(k) Submission Details - K884090

510(k) Number K884090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1988
Decision Date January 24, 1989
Days to Decision 118 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 140d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAD Device Classification - Class 2, Special Controls

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAD Vaporizer, Anesthesia, Non-heated

All 43
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K884090.
OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER
K913593 · Ohmeda Medical · Oct 1992
OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
K892057 · Ohmeda Medical · Apr 1989
VAPAMASTA 5
K884686 · Dentsply Intl. · Mar 1989
VAPLOK
K864605 · Bear Medical Systems, Inc. · Feb 1987
HALOTHANE VAPORIZER 950, ENFLURANE
K841157 · Siemens Elema AB · Jun 1984
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
K821966 · Ohio Medical Products · Jul 1982
K884090 · LUNDY VAPORIZER SYSTEM
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