Cleared Traditional

K892053 - RESPAKIT

K892053 is an FDA 510(k) clearance for RESPAKIT, manufactured by Protectical Health & Safety , Ltd.. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K892053 · Protectical Health & Safety , Ltd. · Anesthesiology device
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Apr 1989
Decision
29d
Days
Class 1
Risk

K892053 is an FDA 510(k) clearance for the RESPAKIT. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Protectical Health & Safety , Ltd. (Washington, US). The FDA issued a Cleared decision on April 27, 1989 after a review of 29 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.

FDA 510(k) Submission Details - K892053

510(k) Number K892053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1989
Decision Date April 27, 1989
Days to Decision 29 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 140d · This submission: 29d
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 K892053.
GUEDEL AIRWAY
K922748 · Oem Medical Div. · Jul 1992
INTAVENT LARYNGEAL MASK
K904834 · Intavent Intl. S.A. · Jul 1991
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
K892053 · RESPAKIT
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