Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION

K-Number: K022391 · 2002-10-21

ApplicantOrgan Recovery Systems, Inc.
Decision Date2002-10-21
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION 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 2002-10-21 under 510(k) number K022391. 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 MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION?

MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION is a medical device that received FDA 510(k) clearance on 2002-10-21. The listed applicant is Organ Recovery Systems, Inc.. The 510(k) number is K022391.

When did MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION receive FDA 510(k) clearance?

MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION received FDA 510(k) clearance on 2002-10-21, under 510(k) number K022391.

Who is the listed applicant for MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION?

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 MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION?

The FDA product code for MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION 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)K013575KPS-I, THE KIDNEY PERFUSION SOLUTION

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

View on FDA Database →

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

↑