Cleared Traditional

K854029 - RESPIRATORY RESUSCITATION DEVICE

K854029 is an FDA 510(k) clearance for RESPIRATORY RESUSCITATION DEVICE, manufactured by John H. Harrison. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K854029 · John H. Harrison · Anesthesiology device
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Mar 1986
Decision
161d
Days
Class 1
Risk

K854029 is an FDA 510(k) clearance for the RESPIRATORY RESUSCITATION DEVICE. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by John H. Harrison (Long Beach, US). The FDA issued a Cleared decision on March 11, 1986 after a review of 161 days - an extended review 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: 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 - K854029

510(k) Number K854029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1985
Decision Date March 11, 1986
Days to Decision 161 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 140d · This submission: 161d
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 26
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K854029.
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
CURITY FIBEROPTIC INTUBATING AIRWAY
K855137 · The Kendal Co. · Mar 1986
DISPOSABLE GUEDEL AIRWAY
K850248 · Inmed Corp. · Mar 1985
RESPIRONICS VENT EASY OXYGEN ENRICHME
K842605 · Respironics, Inc. · Jul 1984
K854029 · RESPIRATORY RESUSCITATION DEVICE
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