510(k) · Cleared
ClearedEasy Care and Tubing Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medionics International, Inc. · FKX System, Peritoneal, Automatic Delivery
Cleared on Feb 10, 2000 as substantially equivalent to K910173 (Medionics International, Ltd., 1992) after a 57-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Feb 10, 2000
- Review
- 57 days
- Class
- Class II
- Product code
- FKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910173 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK910173 Selectra and Tubing SetsMedionics International, Ltd. · 1992
- This deviceK994218 Easy Care and Tubing SetsMedionics International, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910173 | Selectra and Tubing Sets | Medionics International, Ltd. | 1992 | — |
| 0 (this device) | K994218 | Easy Care and Tubing Sets | Medionics International, Inc. | 2000 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FKX? 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 FKX device
- #1 K243371 Byonyks X-1 APD Cycler; Byonyks Automated PD…score 11.1 · 7 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 |
|---|---|---|---|
| * | K910173 | Selectra and Tubing SetsSummary page 2…for Devices and Radiological Health Enclosure Page 9 Page 1 of 1 510(k) Number of our own Legally 510(k) Number (if known): _Marketed Predicate Device K910173/C Device Name: Easy Care and Tubing Sets Indications For Use: Easy Care and Tubing Sets are used to provide peritoneal dialysi… | 1992 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FKX devicesFKX System, Peritoneal, Automatic Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FKX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FKX
209in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FKX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FKX
3,128in 2025
MAUDE reports naming product code FKX, 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 | 0 | — | 2 | 147 |
| 2008 | 0 | — | 0 | 702 |
| 2009 | 0 | — | 0 | 340 |
| 2010 | 0 | — | 5 | 4,966 |
| 2011 | 2 | — | 2 | 11,304 |
| 2012 | 0 | — | 2 | 18,034 |
| 2013 | 2 | — | 1 | 22,093 |
| 2014 | 1 | — | 4 | 28,289 |
| 2015 | 1 | — | 2 | 24,663 |
| 2016 | 0 | — | 1 | 6,137 |
| 2017 | 1 | — | 0 | 3,127 |
| 2018 | 2 | — | 3 | 5,927 |
| 2019 | 0 | — | 0 | 5,972 |
| 2020 | 1 | — | 1 | 4,598 |
| 2021 | 0 | — | 0 | 5,076 |
| 2022 | 4 | 209 | 0 | 4,503 |
| 2023 | 0 | — | 2 | 3,913 |
| 2024 | 0 | — | 0 | 3,771 |
| 2025 | 2 | — | 1 | 3,128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Easy Care and Tubing Sets are used to provide peritoneal dialysis
fluid exchanges for patients suffering from End Stage Renal
Disease (ESRD). Their main function is to allow the bi-directional
flow of peritoneal dialysis solution in and out of the peritoneal
cavity of the patient by means of gravity.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994218: Easy Care and Tubing Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994218
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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