FDA product code KOC: Accessories, Blood Circuit, Hemodialysis
KOC is the FDA product code for accessories, blood circuit, hemodialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 182 510(k) submissions under KOC, 4 in the last five years, from 77 different applicants. The average 510(k) review took 105 days (median 58); 281 days on average over the last three years. FDA has posted 17 recalls for KOC devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Blood Circuit, Hemodialysis |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for KOC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 141 |
| 2020 | 1 | 136 |
| 2023 | 2 | 84 |
| 2025 | 2 | 281 |
Compare with all 510(k) review times · Search every KOC clearance
Top KOC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sorensen Research | 22 | 1979-06-27 |
| Erika, Inc. | 13 | 1984-07-13 |
| Extracorporeal Medical Specialities, Inc. | 11 | 1984-02-04 |
| Gambro, Inc. | 9 | 1983-10-14 |
| Travenol Laboratories, S.A. | 8 | 1984-10-18 |
72 more applicants have KOC clearances. See the full list in Caduvo.
Most recent KOC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242479 | NIKKISO CO., LTD. | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU | 2025-05-15 | 267 |
| K242176 | NIKKISO CO., LTD. | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) | 2025-05-15 | 295 |
| K231589 | NIKKISO CO., LTD. | Blood Tubing Lines for Hemodialysis AV06C-E | 2023-07-28 | 57 |
| K230514 | NIKKISO CO., LTD. | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | 2023-06-16 | 112 |
| K201207 | Fresenius Medical Care Renal Therapies Group, LLC | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line | 2020-09-18 | 136 |
Recalls for KOC devices
17 product recalls in 10 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-08-10.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code KOC?
KOC is the FDA product code for accessories, blood circuit, hemodialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is KOC?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code KOC?
Across 182 cleared submissions the average was 105 days from receipt to decision (median 58).
Which companies have the most KOC clearances?
Sorensen Research (22); Erika, Inc. (13); Extracorporeal Medical Specialities, Inc. (11); Gambro, Inc. (9); Travenol Laboratories, S.A. (8).
Have KOC devices been recalled?
Yes: 17 product recalls across 10 recall events; the most recent began 2026-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code KOC
- Run a recall and safety report across every KOC manufacturer
- Watch product code KOC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times