Cleared Traditional

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 (K971107) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971107 · Alexander Mfg. Co. · General & Plastic Surgery device
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Jun 1997
Decision
71d
Days
Class 2
Risk

K971107 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), 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 General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 K971107 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 General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 37
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K971107.
SOMAVAC Device
K180606 · Somavac Medical Solutions, Inc. · May 2018
Rex Medical Aspiration Pump
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Aprima Smartesis Centesis Pump
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UIMAT PUMP
K953132 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
COOK ASPIRATION/IRRIGATION UNIT
K944818 · Cook Urological, Inc. · Nov 1994
VACPAC PORTABLE ASPIRATION SYSTEM
K910271 · Jedmed Instrument Co. · Mar 1991