Cleared Traditional

K912071 - SPACE(TM) 7500

K912071 is an FDA 510(k) clearance for SPACE(TM) 7500, manufactured by F.M. Wiest USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code IKN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K912071 · F.M. Wiest USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
60d
Days
Class 2
Risk

K912071 is an FDA 510(k) clearance for the SPACE(TM) 7500. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by F.M. Wiest USA, Inc. (Oradell, US). The FDA issued a Cleared decision on July 9, 1991 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 890.1375 - 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 F.M. Wiest USA, Inc. devices

FDA 510(k) Submission Details - K912071

510(k) Number K912071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1991
Decision Date July 09, 1991
Days to Decision 60 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 131d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 42
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K912071.
EXCEL EMG
K941144 · Excel Tech. , Ltd. · Nov 1995
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
K930328 · Bio-Logic Systems Corp. · Jul 1993
PHASIS ELECTROMYOGRAPH
K922488 · Biosound, Inc. · Mar 1993
EMG NAVIGATOR & EMG TRAVELER
K893130 · Bio-Logic Systems Corp. · Mar 1990
MODIFIED NICOLET VIKING SYSTEM
K880573 · Nicolet Biomedical Instruments · Mar 1988
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · Chattanooga Group, Inc. · Dec 1986