Cleared Traditional

K830781 - ENDO-GUARD

K830781 is an FDA 510(k) clearance for ENDO-GUARD, manufactured by Jayco Pharmaceuticals. The device is a Class 1 Anesthesiology device with product code FOG cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K830781 · Jayco Pharmaceuticals · Anesthesiology device
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Mar 1983
Decision
20d
Days
Class 1
Risk

K830781 is an FDA 510(k) clearance for the ENDO-GUARD. Classified as Hood, Oxygen, Infant (product code FOG), Class I - General Controls.

Submitted by Jayco Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on March 31, 1983 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 Jayco Pharmaceuticals devices

FDA 510(k) Submission Details - K830781

510(k) Number K830781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1983
Decision Date March 31, 1983
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
120d faster than avg
Panel avg: 140d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

FOG Device Classification - Class 1, General Controls

Product Code FOG Hood, Oxygen, Infant
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.

Regulatory Peers - FOG Hood, Oxygen, Infant

Devices cleared under the same product code (FOG) and FDA review panel - the closest regulatory comparables to K830781.
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K973128 · Olympus America, Inc. · Nov 1997
BURLEW INFANT HOOD
K962182 · Promedic, Inc. · Jul 1996
SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)
K955482 · Advantage Medical Services, Inc. · Jan 1996
DISPOSA-HOOD
K792144 · Utah Medical Products, Inc. · Dec 1979
HOOD, INFANT OXYGEN
K780220 · Shiley, Inc. · Apr 1978