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)

OLPUR DIALYZER, MODEL HD 190

K-Number: K050603 · 2005-06-09

ApplicantNephros, Inc.
Decision Date2005-06-09
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLPUR DIALYZER, MODEL HD 190 is the device name listed in this FDA 510(k) record. The listed applicant is Nephros, Inc.. It received FDA 510(k) clearance on 2005-06-09 under 510(k) number K050603. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLPUR DIALYZER, MODEL HD 190?

OLPUR DIALYZER, MODEL HD 190 is a medical device that received FDA 510(k) clearance on 2005-06-09. The listed applicant is Nephros, Inc.. The 510(k) number is K050603.

When did OLPUR DIALYZER, MODEL HD 190 receive FDA 510(k) clearance?

OLPUR DIALYZER, MODEL HD 190 received FDA 510(k) clearance on 2005-06-09, under 510(k) number K050603.

Who is the listed applicant for OLPUR DIALYZER, MODEL HD 190?

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

What is the FDA product code for OLPUR DIALYZER, MODEL HD 190?

The FDA product code for OLPUR DIALYZER, MODEL HD 190 is KDI.

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 Nephros, 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.

K161304EndoPur FilterK161467HydraGuard 10 UltraFilterK153084Nephros S100K112314NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTERK110285NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTERK090885NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER

View all 7 devices →

Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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.

↑