Cleared Traditional

K864605 - VAPLOK

K864605 is the FDA 510(k) clearance for VAPLOK by Bear Medical Systems, Inc.. It is a Class 2 Anesthesiology device (product code CAD) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K864605 · Bear Medical Systems, Inc. · Anesthesiology device
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Feb 1987
Decision
71d
Days
Class 2
Risk

K864605 is an FDA 510(k) clearance for the VAPLOK. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Bear Medical Systems, Inc. (Riverside, US). The FDA issued a Cleared decision on February 3, 1987 after a review of 71 days - a notably fast clearance cycle.

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: 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 Bear Medical Systems, Inc. devices

Submission Details

510(k) Number K864605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1986
Decision Date February 03, 1987
Days to Decision 71 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 140d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 15
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K864605.
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
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS
K821650 · Draeger Medical, Inc. · Jun 1982
VAPOR 19
K771899 · Draeger Medical, Inc. · Oct 1977