Cleared Traditional

K830778 - MONITORING KIT AMK-1 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830778 · Alternative Design Systems, Inc. · Anesthesiology device
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Oct 1983
Decision
217d
Days
Class 2
Risk

K830778 is an FDA 510(k) clearance for the MONITORING KIT AMK-1. Classified as Monitor, Apnea, Facility Use (product code FLS), Class II - Special Controls.

Submitted by Alternative Design Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 217 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2377 - 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.

View all Alternative Design Systems, Inc. devices

Submission Details

510(k) Number K830778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1983
Decision Date October 14, 1983
Days to Decision 217 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 139d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLS Monitor, Apnea, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2377
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.