Cleared Special

K201765 - SmartHDM-510 System

K201765 is an FDA 510(k) clearance for SmartHDM-510 System, manufactured by Mesa Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIZ cleared through the Special 510(k) pathway after a 65-day FDA review.

K201765 · Mesa Laboratories, Inc. · Gastroenterology & Urology device
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Sep 2020
Decision
65d
Days
Class 2
Risk

K201765 is an FDA 510(k) clearance for the SmartHDM-510 System. Classified as Meter, Conductivity, Non-remote (product code FIZ), Class II - Special Controls.

Submitted by Mesa Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 2, 2020 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mesa Laboratories, Inc. devices

FDA 510(k) Submission Details - K201765

510(k) Number K201765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2020
Decision Date September 02, 2020
Days to Decision 65 days
Submission Type Special
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
66d faster than avg
Panel avg: 131d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

FIZ Device Classification - Class 2, Special Controls

Product Code FIZ Meter, Conductivity, Non-remote
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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

Ibp Medical GmbH
Johannes Pfingstmann

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 - FIZ Meter, Conductivity, Non-remote

Devices cleared under the same product code (FIZ) and FDA review panel - the closest regulatory comparables to K201765.
Phoenix XL Dialysate Meter
K150657 · Mesa Laboratories, Inc. · Sep 2015
90XL INSTRUMENTATION SYSTEM
K050812 · Mesa Laboratories, Inc. · May 2005
NEO-2 METER
K992431 · Automata Instrumentation, Inc. · Oct 1999
ODYSSEY INSTRUMENTATION SYSTEM
K981294 · Automata Instrumentation, Inc. · Jul 1998
PHOENIX DIALYSATE METER
K955298 · Automata Medical Instrumentation, Inc. · Feb 1996