Cleared Traditional

K830421 - SYN-02 PN AMPLIFIER

K830421 is the FDA 510(k) clearance for SYN-02 PN AMPLIFIER by Biosearch Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFX) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K830421 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1983
Decision
57d
Days
Class 2
Risk

K830421 is an FDA 510(k) clearance for the SYN-02 PN AMPLIFIER. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983 after a review of 57 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 Biosearch Medical Products, Inc. devices

Submission Details

510(k) Number K830421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1983
Decision Date April 06, 1983
Days to Decision 57 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
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K830421.
Lehman Manometry Catheter
K160170 · Wilson-Cook Medical, Inc. · Jun 2016
WILSON-COOK BILIARY MOTILITY CATHETER
K900058 · Wilson-Cook Medical, Inc. · Jul 1990
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
K874690 · Mentor Corp. · Feb 1988
ESOPHAGEAL MOTILITY APPARATUS
K812103 · Honeywell, Inc. · Aug 1981
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
K780812 · Honeywell, Inc. · Jun 1978
ESOPHAGEAL MOTILITY TUBE
K760761 · Sherwood Medical Industries · Nov 1976