Cleared Traditional

K821966 - MODULUS VERNI-TROL ANESTHETIC VAPORIZER

K821966 is the FDA 510(k) clearance for MODULUS VERNI-TROL ANESTHETIC VAPORIZER by Ohio Medical Products. It is a Class 2 Anesthesiology device (product code CAD) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821966 · Ohio Medical Products · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
14d
Days
Class 2
Risk

K821966 is an FDA 510(k) clearance for the MODULUS VERNI-TROL ANESTHETIC VAPORIZER. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on July 16, 1982 after a review of 14 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 Ohio Medical Products devices

Submission Details

510(k) Number K821966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1982
Decision Date July 16, 1982
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
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 16
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K821966.
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
HALOTHANE VAPORIZER 950, & ENFLURANE 951
K790359 · Siemens Corp. · Mar 1979
VAPOR 19
K771899 · Draeger Medical, Inc. · Oct 1977