Cleared Traditional

K844622 - SAV-A-LIFE

K844622 is an FDA 510(k) clearance for SAV-A-LIFE, manufactured by Southern Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K844622 · Southern Medical Products, Inc. · Anesthesiology device
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Feb 1985
Decision
91d
Days
Class 1
Risk

K844622 is an FDA 510(k) clearance for the SAV-A-LIFE. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Southern Medical Products, Inc. (Cape Coral, US). The FDA issued a Cleared decision on February 26, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - 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 Southern Medical Products, Inc. devices

FDA 510(k) Submission Details - K844622

510(k) Number K844622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date February 26, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

CAN Device Classification - Class 1, General Controls

Product Code CAN Regulator, Pressure, Gas Cylinder
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
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 - CAN Regulator, Pressure, Gas Cylinder

All 20
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K844622.
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K810679 · Instrumentation Industries, Inc. · Apr 1981
REGULATOR, OXYGEN MECHANICAL
K803207 · Timeter Instrument Corp. · Jan 1981