Cleared Traditional

K971865 - ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (FDA 510(k) Clearance)

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

K971865 · Alexander Mfg. Co. · General Hospital
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Jul 1997
Decision
44d
Days
Class 2
Risk

K971865 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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: 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 K971865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1997
Decision Date July 03, 1997
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 128d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDR Controller, Infusion, Intravascular, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.