Cleared Traditional

K844873 - PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K844873 · Pennine Medical , Ltd. · Anesthesiology device
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Feb 1985
Decision
66d
Days
Class 1
Risk

K844873 is an FDA 510(k) clearance for the PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Pennine Medical , Ltd. (Derby, GB). The FDA issued a Cleared decision on February 21, 1985 after a review of 66 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 Pennine Medical , Ltd. devices

Submission Details

510(k) Number K844873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1984
Decision Date February 21, 1985
Days to Decision 66 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 139d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.