Cleared Traditional

K091070 - MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM

K091070 is an FDA 510(k) clearance for MANOSCAN MOTILITY WITH IMPEDANCE VISUAL..., manufactured by Sierra Scientific Instruments, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K091070 · Sierra Scientific Instruments, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
35d
Days
Class 2
Risk

K091070 is an FDA 510(k) clearance for the MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Sierra Scientific Instruments, Inc. (Los Angeles, US). The FDA issued a Cleared decision on May 19, 2009 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - 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 Sierra Scientific Instruments, Inc. devices

FDA 510(k) Submission Details - K091070

510(k) Number K091070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2009
Decision Date May 19, 2009
Days to Decision 35 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 131d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FFX Device Classification - Class 2, Special Controls

Product Code FFX System, Gastrointestinal Motility (electrical)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FFX System, Gastrointestinal Motility (electrical)

All 52
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K091070.
ENDO FLIP
K102214 · Crospon, Ltd. · Dec 2010
PHTIP DISPOSABLE ISFET CATHETER
K102801 · E-Cath Co., Ltd. · Oct 2010
ENDOFLIP
K092850 · Crospon, Ltd. · Dec 2009
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
K082056 · Life-Tech, Inc. · Nov 2008
MODIFICATION TO SOLAR GI
K071094 · Medical Measurement Systems B.V. · Aug 2007
UNITIP HIGH RESOLUTION CATHETER
K062222 · Unisensor AG · Mar 2007

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.