Cleared Traditional

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (K190208) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190208 · Diversatek Healthcare · Gastroenterology & Urology device
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Oct 2019
Decision
241d
Days
Class 2
Risk

K190208 is an FDA 510(k) clearance for the Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Diversatek Healthcare (Highlands Ranch, US). The FDA issued a Cleared decision on October 3, 2019 after a review of 241 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diversatek Healthcare devices

Submission Details

510(k) Number K190208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2019
Decision Date October 03, 2019
Days to Decision 241 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 130d · This submission: 241d
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 12
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K190208.
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SITZMARKS
K181750 · Konsyl Pharmaceuticals · Nov 2018