Cleared Traditional

K881609 - SITZMARKS

K881609 is an FDA 510(k) clearance for SITZMARKS, manufactured by Lafayette Pharmacal, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K881609 · Lafayette Pharmacal, Inc. · Gastroenterology & Urology device
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Jul 1988
Decision
87d
Days
Class 2
Risk

K881609 is an FDA 510(k) clearance for the SITZMARKS. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Lafayette Pharmacal, Inc. (Lafayette, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 87 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 Lafayette Pharmacal, Inc. devices

FDA 510(k) Submission Details - K881609

510(k) Number K881609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1988
Decision Date July 08, 1988
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
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 19
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K881609.
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K812103 · Honeywell, Inc. · Aug 1981