Cleared Traditional

K971107 - ALEXANDER MANUFACTURING CO. RECHARGEABL...

K971107 is an FDA 510(k) clearance for ALEXANDER MANUFACTURING CO. RECHARGEABL..., manufactured by Alexander Mfg. Co.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K971107 · Alexander Mfg. Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K971107

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
Combination Product No
PCCP Authorized No
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.

BTA Device Classification - Class 2, Special Controls

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 77
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K971107.
KSEA UNIMAT 45
K981703 · Karl Storz Endoscopy · Aug 1998
EASYGO ASPIRATOR
K971749 · Precision Medical, Inc. · Apr 1998
PSI-TEC ASPIRATOR
K980392 · Byron Medical · Mar 1998
UIMAT PUMP
K953132 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
AMBU PORTABLE SUCTION UNIT
K932031 · Ambu, Inc. · May 1995
ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT
K951423 · Impact Instrumentation, Inc. · Apr 1995