Cleared Traditional

K882500 - VAPORIZER

K882500 is the FDA 510(k) clearance for VAPORIZER by Anesthetic Vaporizer Services. It is a Class 2 Anesthesiology device (product code CAD) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K882500 · Anesthetic Vaporizer Services · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
45d
Days
Class 2
Risk

K882500 is an FDA 510(k) clearance for the VAPORIZER, ANESTHESIA, NON-HEATED. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Anesthetic Vaporizer Services (Clarence, US). The FDA issued a Cleared decision on August 1, 1988 after a review of 45 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 Anesthetic Vaporizer Services devices

Submission Details

510(k) Number K882500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1988
Decision Date August 01, 1988
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 140d · This submission: 45d
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 K882500.
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