Cleared Traditional

K980224 - ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K980224 · Alexander Mfg. Co. · General & Plastic Surgery device
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Apr 1998
Decision
70d
Days
Class 1
Risk

K980224 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822. Classified as Battery, Replacement, Rechargeable (product code MOQ), Class I - General Controls.

Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on April 2, 1998 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery 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 Alexander Mfg. Co. devices

Submission Details

510(k) Number K980224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1998
Decision Date April 02, 1998
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 114d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOQ Battery, Replacement, Rechargeable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.