510(k) · Cleared
ClearedMedisystems Dialysis Priming Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisystems Corp. · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Aug 18, 1997 as substantially equivalent to K811837 (Medisystems Corp., 1981) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Aug 18, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K811837 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK811837 I.V. Administration SetMedisystems Corp. · 1981
- This deviceK971860 Medisystems Dialysis Priming SetsMedisystems Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811837 | I.V. Administration Set | Medisystems Corp. | 1981 | — |
| 0 (this device) | K971860 | Medisystems Dialysis Priming Sets | Medisystems Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K811837 | I.V. Administration SetSummary page 1…Equivalence is Claimed: The Dialysis Priming Sets which are the subject of this submission are substantially equivalent to those described in Medisystems’ 510(k) number K811837 and in Japan Medical Co., LTD. 510(k) number K895882. VII. Product Description: The Medisystems Dialysis Priming Sets provide a… | 1981 |
| * | K895882 | JMS Dialyzer Priming SetSummary page 1…ich are the subject of this submission are substantially equivalent to those described in Medisystems’ 510(k) number K811837 and in Japan Medical Co., LTD. 510(k) number K895882. VII. Product Description: The Medisystems Dialysis Priming Sets provide a means of delivering fluids and medicaments from a col… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
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 proposed Dialysis Priming Sets are indicated for use to provide a means to deliver fluids and medicaments from a collapsible container or vented bottle into a patient's vascular system during dialysis procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971860: Medisystems Dialysis Priming Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971860
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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