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Dextrolyte II Peritoneal Dialysis 48-3029-7 Clamp

FDA 510(k)

Class II (US FDA 510(k))

510(k) K920697

by National Medical Care, Medical Products Div., Inc.

Identifiers

510(k) Number
K920697 FDA 510(k)
FDA Product Code
FJH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5830 FDA 510(k)
Regulation Number
876.5830 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a disposable dialyzer used in peritoneal dialysis, classified under the Gastroenterology and Urology medical specialties. It is identified as a substantially equivalent device under FDA 510(k) clearance K920697, with product code FJH and regulation number 876.5830.

It is supplied as a single-use, disposable device intended for clinical use in peritoneal dialysis procedures. The device is manufactured by National Medical Care, Medical Products Div., Inc., and has received FDA 510(k) clearance as a Class II medical device.

Frequently asked questions

What is the DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP used for?

It is a disposable dialyzer used in peritoneal dialysis procedures, intended for clinical use to remove waste and excess fluid from the blood when the kidneys are not functioning adequately, as part of renal replacement therapy.

Is the DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP reusable or single-use?

The device is supplied as a single-use, disposable device, meaning it is intended for one patient and one procedure only, then discarded to prevent cross-contamination and ensure sterility and safety.

How is the DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP supplied and stored?

It is supplied as a sterile, disposable unit in individual packaging, designed for immediate clinical use; storage should follow standard medical device guidelines for disposable products in a clean, dry environment until point of use.

What regulatory pathway was used for the DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP?

The device received FDA 510(k) clearance under K920697 as a substantially equivalent device, meaning it was demonstrated to be as safe and effective as a legally marketed predicate device for the same intended use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF K920697 - Dextrolyte Ii Peritoneal Dialysis 48-3029-7 Clamp, DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP… - FDA.report, K895990 FDA 510(k) - DEXTROLYTE II PERITONEAL DIALYSIS CYCLE..., PDF K920697 - Dextrolyte Ii Peritoneal Dialysis 48-3029-7 Clamp

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
National Medical Care, Medical Products Div., Inc.

Sources (1)

  • FDA 510(k) K920697 24 fields · synced Oct 6, 2026