Cleared Traditional

K150657 - Phoenix XL Dialysate Meter

K150657 is an FDA 510(k) clearance for Phoenix XL Dialysate Meter, manufactured by Mesa Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIZ cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K150657 · Mesa Laboratories, Inc. · Gastroenterology & Urology device
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Sep 2015
Decision
192d
Days
Class 2
Risk

K150657 is an FDA 510(k) clearance for the Phoenix XL Dialysate Meter. 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 21, 2015 after a review of 192 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Mesa Laboratories, Inc. devices

FDA 510(k) Submission Details - K150657

510(k) Number K150657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2015
Decision Date September 21, 2015
Days to Decision 192 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
61d slower than avg
Panel avg: 131d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FIZ Meter, Conductivity, Non-remote

Devices cleared under the same product code (FIZ) and FDA review panel - the closest regulatory comparables to K150657.
SmartHDM-510 System
K201765 · Mesa Laboratories, Inc. · Sep 2020
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