Cleared Traditional

K832642 - ALPHA-I

K832642 is an FDA 510(k) clearance for ALPHA-I, manufactured by Johnson Flexgroup. The device is a Class 1 General Hospital device with product code LHC cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K832642 · Johnson Flexgroup · General Hospital
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Nov 1983
Decision
109d
Days
Class 1
Risk

K832642 is an FDA 510(k) clearance for the ALPHA-I. Classified as Warmer, Irrigation Solution (product code LHC), Class I - General Controls.

Submitted by Johnson Flexgroup (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5950 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Johnson Flexgroup devices

FDA 510(k) Submission Details - K832642

510(k) Number K832642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1983
Decision Date November 21, 1983
Days to Decision 109 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

LHC Device Classification - Class 1, General Controls

Product Code LHC Warmer, Irrigation Solution
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5950
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.