KOC — Accessories, Blood Circuit, Hemodialysis Class II
FDA product code KOC covers "Accessories, Blood Circuit, Hemodialysis", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KOC
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242479 | nikkiso co | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR | May 15, 2025 |
| K242176 | nikkiso co | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR | May 15, 2025 |
| K231589 | nikkiso co | Blood Tubing Lines for Hemodialysis AV06C-E | July 28, 2023 |
| K230514 | nikkiso co | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for | June 16, 2023 |
| K201207 | fresenius medical care renal therapies group | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and In | September 18, 2020 |
| K172238 | fresenius medical care renal therapies group | CAREline Airless Hemodialysis Blood Tubing Sets | December 14, 2017 |
| K160749 | fresenius medical care renal therapies group | CRIT-LINE III Blood Chamber II | April 15, 2016 |
| K152953 | fresenius medical care north america | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | November 5, 2015 |
| K141997 | fresenius medical care | CRIT-LINE IV SYSTEM | April 1, 2015 |
| K141281 | fresenius medical care renal therapies group | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | August 14, 2014 |
| K121599 | fresenius medical care-north america | CRIT-LINE CLIP (CLIC) | November 9, 2012 |
| K082719 | nikkiso co | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, | March 30, 2009 |
| K081740 | innovations for access | HEMOBAND, MODELS HB-NS AND HB-NSXL | March 12, 2009 |
| K082758 | stihler electronic | PRISMAFLO II | December 19, 2008 |
| K081043 | nxstage medical | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | July 7, 2008 |
| K071909 | barkey gmbh and co. kg | PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R | October 18, 2007 |
| K030456 | vasc-alert | VASC-ALERT | July 11, 2003 |
| K022536 | fresenius medical care | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RES | October 30, 2002 |
| K020103 | stihler electronic | PRISMAFLO | July 24, 2002 |
| K003712 | molded products | MODIFICATION TO MALE TO MALE LUER ADAPTER | May 16, 2001 |