510(k) · Cleared
Recalled · Class II · 2014\Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Oct 30, 2002 as substantially equivalent to K994306 (Medisystems Corp., 2000) after a 90-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 30, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KOC
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953823 (1996). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK953823 Arterial Venous Blood Tubing SetMedisystems Corp. · 1996
- 1 generation backK994306 ReversoMedisystems Corp. · 2000
- This deviceK022536 \Resenius Access Flow Reserving Connectors, Fresenius Standalone…Fresenius Medical Care · 2002
- Descendant · cites it directly · 6 of its ownK172238 CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC · 2017
- Descendant · 2 generations on · 5 of its ownK201207 CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached…Fresenius Medical Care Renal Therapies Group, LLC · 2020
- Descendant · 2 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
- Descendant · 3 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
- Descendant · 3 generations on · 1 of its ownK213992 CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 2023 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC · 2017 · cites it directly6descendants
- K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…Fresenius Medical Care Renal Therapies Group, LLC · 2020 · 2 generations on5descendants
- K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 2 generations on2descendants
- K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on1descendant
- K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953823 | Arterial Venous Blood Tubing Set | Medisystems Corp. | 1996 | — |
| −1 | K994306 | Reverso | Medisystems Corp. | 2000 | — |
| 0 (this device) | K022536 | \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow… | Fresenius Medical Care | 2002 | — |
| +1 | K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | Fresenius Medical Care Renal Therapies Group, LLC | 2017 | — |
| +2 | K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and… | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | — |
| +2 | K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024 | 1 |
| +3 | K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 6 |
| +3 | K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KOC device
- #1 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994306 | ReversoSummary page 1…Regurgitation Valve - Class I1 Device Product Code and Panel Code: KOC, 78 Predicate Device: Medisystems Blood Tubing Set Accessories (Reversn'"); K994306, SE 3/20/200Q Description: The Fresenius Access Flow Reversing Connector is designed to be used during hemod… | 2000 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | 2017 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2014 | Class II | Z-1047-2015 | Device Design | Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope |
| Nov 25, 2008 | Not classified | Z-0859-2009 | Process control | Port may crack and separate resulting in potential blood exposure/blood loss for the patient |
| Nov 25, 2008 | Not classified | Z-0860-2009 | Process control | Port may crack and separate resulting in potential blood exposure/blood loss for the patient |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K172238 (Fresenius Medical Care Renal Therapies Group, LLC, 2017) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K994306.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOC
Too few KOC 510(k)s in any year since 2007 to give a median.
Recalls per year · KOC
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOC
50in 2025
MAUDE reports naming product code KOC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 2 | 12 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 1 | — | 1 | 165 |
| 2015 | 2 | — | 0 | 555 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 23 |
| 2018 | 0 | — | 3 | 37 |
| 2019 | 0 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 2 | — | 0 | 50 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement.
The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure.
It may be used in conjunction with access devices, such as; the Fresenius Online Clearance Monitor, the CritLine@from HemaMetrics, or the HDO 1 Hemodialysis Monitor from Transonic Systems when flow reversal is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022536 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022536: \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022536
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026