Cleared Traditional

K970799 - ALEXANDER MANUFACTURING RECHARGEABLE BA...

K970799 is an FDA 510(k) clearance for ALEXANDER MANUFACTURING RECHARGEABLE BA..., manufactured by Alexander Mfg. Co.. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K970799 · Alexander Mfg. Co. · Gastroenterology & Urology device
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May 1997
Decision
71d
Days
Class 2
Risk

K970799 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T). Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on May 14, 1997 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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 - K970799

510(k) Number K970799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date May 14, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIF Device Classification - Class 2, Special Controls

Product Code LIF Dialyzer Reprocessing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LIF Dialyzer Reprocessing System

All 26
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K970799.
RENACLEAN SH DIALYZER CLEANING SYSTEM
K033505 · Minntech Corp. · Apr 2004
RENACLEAR DIALYZER CLEANING SYSTEM
K991851 · Minntech Corp. · Aug 1999
DPS 4 DIALYZER PREPARATION SYSTEM
K955299 · Seratronics, Inc. · Oct 1996
DRS 4 DIALYZER REPROCESSING SYSTEM
K931336 · Seratronics, Inc. · Apr 1996
FORMALIN REUSE CART
K941757 · National Medical Care, Medical Products Div., Inc. · Jan 1996
DRS 4 ND DIALYZER REPROCESSING SYSTEM
K944539 · Seratronics, Inc. · Nov 1995