Cleared Traditional

K020909 - HDM99

K020909 is an FDA 510(k) clearance for HDM99, manufactured by Ibp Instruments GmbH. The device is a Class 2 Gastroenterology & Urology device with product code FIZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K020909 · Ibp Instruments GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
63d
Days
Class 2
Risk

K020909 is an FDA 510(k) clearance for the HDM99. Classified as Meter, Conductivity, Non-remote (product code FIZ), Class II - Special Controls.

Submitted by Ibp Instruments GmbH (Hannover, DE). The FDA issued a Cleared decision on May 22, 2002 after a review of 63 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. 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 Ibp Instruments GmbH devices

FDA 510(k) Submission Details - K020909

510(k) Number K020909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2002
Decision Date May 22, 2002
Days to Decision 63 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 131d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Tuv America, Inc.
MARK JOB

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

All 7
Devices cleared under the same product code (FIZ) and FDA review panel - the closest regulatory comparables to K020909.
Phoenix XL Dialysate Meter
K150657 · Mesa Laboratories, Inc. · Sep 2015
90XL INSTRUMENTATION SYSTEM
K050812 · Mesa Laboratories, Inc. · May 2005
HDM97
K020908 · Ibp Instruments GmbH · May 2002
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

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.