Clirans E-Series Dialyzer
510(k) K013550
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013550 | Date20 Nov 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KDI
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5860
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Clirans E-Series Dialyzer is a high‑permeability dialyzer, classified as a dialyzer with or without a sealed dialysate system. It is designed for use in hemodialysis procedures within gastroenterology and urology settings, employing hollow‑fiber technology to facilitate efficient solute clearance.
The device is supplied by Terumo Medical Corp. under the trade name Clirans E-Series Dialyzer (K013550) and was cleared through the FDA 510(k) special pathway as a Class 2 device (product code KDI) under 21 CFR 876.5860. It is identified as a single‑use, sterile medical device intended for clinical use according to the manufacturer’s labeling.
Other devices from Terumo Medical Corporation
Questions
AI-generated answers, 19 Sep 2026
What medical specialties is the Clirans E-Series Dialyzer primarily used in, and why is it designed for these fields?
The Clirans E-Series Dialyzer is primarily used in gastroenterology and urology settings. It employs hollow-fiber technology to efficiently clear solutes during hemodialysis, which is critical for managing metabolic waste and fluid balance in patients with kidney-related conditions—commonly addressed in these specialties. The high-permeability design ensures effective solute removal, making it suitable for procedures where precise filtration is required.
Is the Clirans E-Series Dialyzer reusable, or is it intended for single-use only? How does this affect its clinical use?
The Clirans E-Series Dialyzer is intended for single-use only, as explicitly stated in the manufacturer’s labeling. This design ensures sterility and reduces the risk of cross-contamination between patients, which is critical in hemodialysis to maintain patient safety and compliance with infection control protocols. Single-use also simplifies inventory management and eliminates the need for reprocessing.
What does the FDA’s clearance pathway for this device indicate about its regulatory status and intended use?
The Clirans E-Series Dialyzer was cleared through the FDA 510(k) special pathway under product code KDI (Dialyzer, High Permeability) as a Class II device. This clearance confirms it meets FDA standards for safety and effectiveness as a single-use, sterile medical device for hemodialysis. The pathway does not define clinical indications but confirms regulatory compliance for use in gastroenterology and urology procedures, as referenced in the advisory committee records.
How is the Clirans E-Series Dialyzer supplied, and what should clinicians consider when storing it?
The device is supplied sterile and single-use by Terumo Medical Corp. under the trade name *Clirans E-Series Dialyzer*. Clinicians should store it in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and functionality. Since it’s intended for one-time use, proper inventory tracking is essential to avoid expiration or misuse. Always follow the manufacturer’s storage guidelines to ensure optimal performance.
Are there multiple sizes or models available for the Clirans E-Series Dialyzer, and how might this affect patient selection?
The Clirans E-Series Dialyzer comes in multiple configurations, as indicated by the diverse FEI numbers (e.g., 3002806443, 3002807196, etc.), which likely correspond to variations in membrane surface area, blood flow rates, or dialysate flow rates. These differences allow clinicians to select a model tailored to a patient’s dialysis prescription, body size, and metabolic needs. For example, larger surface areas may be preferred for patients requiring higher clearance rates, while smaller models could suit pediatric or low-volume dialysis scenarios.