Cleared Traditional

K971099 - ALEXANDER MANUFACTURING CO. RECHARGEABL...

K971099 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 HGM cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K971099 · Alexander Mfg. Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
71d
Days
Class 2
Risk

K971099 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on June 5, 1997 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - 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 - K971099

510(k) Number K971099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1997
Decision Date June 05, 1997
Days to Decision 71 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
89d faster than avg
Panel avg: 160d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
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.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 103
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K971099.
FETALGARD 3000 FETAL MONITOR
K983395 · Analogic Corp. · Aug 1999
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
K974248 · Air-Shields, Inc. · Oct 1998
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
K965008 · Spacelabs Medical, Inc. · Dec 1997
CARD GUARD MODEL CG-900
K960553 · Card Guard Scientific Survival , Ltd. · Apr 1997
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K964770 · Ge Medical Systems Information Technologies · Feb 1997
COROMETRICS FETAL MOVEMENT DETECTION KIT
K955559 · Ge Medical Systems Information Technologies · Mar 1996