Cleared Traditional

K862199 - MEDTECH C.P.R. MASK

K862199 is an FDA 510(k) clearance for MEDTECH C.P.R. MASK, manufactured by The Medtech Group, Inc.. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K862199 · The Medtech Group, Inc. · Anesthesiology device
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Jun 1986
Decision
3d
Days
Class 1
Risk

K862199 is an FDA 510(k) clearance for the MEDTECH C.P.R. MASK. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by The Medtech Group, Inc. (South Planifield, US). The FDA issued a Cleared decision on June 13, 1986 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - 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 The Medtech Group, Inc. devices

FDA 510(k) Submission Details - K862199

510(k) Number K862199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1986
Decision Date June 13, 1986
Days to Decision 3 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 140d · This submission: 3d
Pathway characteristics
Predicate-based equivalence.

CAE Device Classification - Class 1, General Controls

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
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 - CAE Airway, Oropharyngeal, Anesthesiology

All 23
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K862199.
GUEDEL AIRWAY
K953400 · Mallinckrodt Medical · Oct 1995
BERMAN AIRWAY
K936134 · Smiths Industries Medical Systems, Inc. · Jan 1994
ORAL AIRWAY
K891586 · Dynarex Corp. · May 1989
DUAL-AID
K860949 · Vitalograph , Ltd. · May 1986
DISPOSABLE BERMAN AND GUEDEL AIRWAYS
K861540 · Dryden Corp. · May 1986
DISPOSABLE RESCUE BREATHING DEVICE
K861054 · B & F Medical Products, Inc. · Apr 1986