Cleared Traditional

K971240 - ALEXANDER MANUFACTURING CO. RECHARGEABL...

K971240 is an FDA 510(k) clearance for ALEXANDER MANUFACTURING CO. RECHARGEABL..., manufactured by Alexander Mfg. Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HEL cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K971240 · Alexander Mfg. Co. · Obstetrics & Gynecology device
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Jun 1997
Decision
65d
Days
Class 2
Risk

K971240 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006. Classified as Monitor, Heart Rate, Fetal, Ultrasonic (product code HEL), Class II - Special Controls.

Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on June 6, 1997 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - 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

FDA 510(k) Submission Details - K971240

510(k) Number K971240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1997
Decision Date June 06, 1997
Days to Decision 65 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 160d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEL Device Classification - Class 2, Special Controls

Product Code HEL Monitor, Heart Rate, Fetal, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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.