Cleared Traditional

K972746 - ALEXANDER MANUFACTURING CO. RECHARGEABL...

K972746 is an FDA 510(k) clearance for ALEXANDER MANUFACTURING CO. RECHARGEABL..., manufactured by Alexander Mfg. Co.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972746 · Alexander Mfg. Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
90d
Days
Class 2
Risk

K972746 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on October 21, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Alexander Mfg. Co. devices

FDA 510(k) Submission Details - K972746

510(k) Number K972746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1997
Decision Date October 21, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 304
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K972746.
ANS 2000 ECG MONITOR AND RESPIRATION PACER
K973426 · D. E. Hokanson, Inc. · Aug 1998
M1765A ECG MANAGER
K974746 · Hewlett-Packard Co. · Mar 1998
FORMULA FOR ARCHIMED
K974079 · Biosound Esaote, Inc. · Jan 1998
SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS
K972199 · Marquette Electronics, Inc. · Sep 1997
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH
K972310 · Nihon Kohden America, Inc. · Aug 1997
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
K964784 · Quinton, Inc. · Aug 1997