Cleared Traditional

K812103 - ESOPHAGEAL MOTILITY APPARATUS

K812103 is an FDA 510(k) clearance for ESOPHAGEAL MOTILITY APPARATUS, manufactured by Honeywell, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K812103 · Honeywell, Inc. · Gastroenterology & Urology device
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Aug 1981
Decision
20d
Days
Class 2
Risk

K812103 is an FDA 510(k) clearance for the ESOPHAGEAL MOTILITY APPARATUS. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Honeywell, Inc. (Walker, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 20 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 Honeywell, Inc. devices

FDA 510(k) Submission Details - K812103

510(k) Number K812103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1981
Decision Date August 13, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 130d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FFX System, Gastrointestinal Motility (electrical)

All 18
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K812103.
WILSON-COOK BILIARY MOTILITY CATHETER
K900058 · Wilson-Cook Medical, Inc. · Jul 1990
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
K874690 · Mentor Corp. · Feb 1988
SYN-02 PN AMPLIFIER
K830421 · Biosearch Medical Products, Inc. · Apr 1983
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
K780812 · Honeywell, Inc. · Jun 1978
ESOPHAGEAL MOTILITY TUBE
K760761 · Sherwood Medical Industries · Nov 1976