Cleared Traditional

K020908 - HDM97

K020908 is an FDA 510(k) clearance for HDM97, 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.

K020908 · Ibp Instruments GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
63d
Days
Class 2
Risk

K020908 is an FDA 510(k) clearance for the HDM97. 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 - K020908

510(k) Number K020908 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
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 130d · 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.