Cleared Traditional

K852345 - SEA-LONG NECKSEAL & HOOD (FDA 510(k) Clearance)

Class I Anesthesiology device.

K852345 · Safety Sea Systems, Inc. · Anesthesiology device
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Jun 1985
Decision
20d
Days
Class 1
Risk

K852345 is an FDA 510(k) clearance for the SEA-LONG NECKSEAL & HOOD. Classified as Tent, Oxygen (product code BYL), Class I - General Controls.

Submitted by Safety Sea Systems, Inc. (Ponchatoula, US). The FDA issued a Cleared decision on June 20, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5700 - 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 Safety Sea Systems, Inc. devices

Submission Details

510(k) Number K852345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date June 20, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 139d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYL Tent, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5700
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.