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FDA 510(k)

KPS-I, THE KIDNEY PERFUSION SOLUTION

K-Number: K013575 · 2002-01-25

ApplicantOrgan Recovery Systems, Inc.
Decision Date2002-01-25
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KPS-I, THE KIDNEY PERFUSION SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Organ Recovery Systems, Inc.. It received FDA 510(k) clearance on 2002-01-25 under 510(k) number K013575. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KPS-I, THE KIDNEY PERFUSION SOLUTION?

KPS-I, THE KIDNEY PERFUSION SOLUTION is a medical device that received FDA 510(k) clearance on 2002-01-25. The listed applicant is Organ Recovery Systems, Inc.. The 510(k) number is K013575.

When did KPS-I, THE KIDNEY PERFUSION SOLUTION receive FDA 510(k) clearance?

KPS-I, THE KIDNEY PERFUSION SOLUTION received FDA 510(k) clearance on 2002-01-25, under 510(k) number K013575.

Who is the listed applicant for KPS-I, THE KIDNEY PERFUSION SOLUTION?

The FDA 510(k) record lists Organ Recovery Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KPS-I, THE KIDNEY PERFUSION SOLUTION?

The FDA product code for KPS-I, THE KIDNEY PERFUSION SOLUTION is KDN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Organ Recovery Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091656SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2LK021362LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)K022391MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION

Related Devices (Code: KDN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261644Perfadex PlusXvivo Perfusion ABK260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges Lopez

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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