Cleared Traditional

K973850 - ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 (FDA 510(k) Clearance)

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

K973850 · Alexander Mfg. Co. · Obstetrics & Gynecology device
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Nov 1997
Decision
35d
Days
Class 2
Risk

K973850 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007. Classified as Recorder, Pressure, Intrauterine (product code HFO), Class II - Special Controls.

Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on November 12, 1997 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2700 - the FDA obstetrics and gynecology 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 K973850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1997
Decision Date November 12, 1997
Days to Decision 35 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 160d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HFO Recorder, Pressure, Intrauterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2700
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 Obstetrics & Gynecology devices follow this clearance model.