510(k) · Cleared
Recalled · Class II · 2021Cycler Drain Bag Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Cleared on Jan 24, 2018 as substantially equivalent to K895991 (National Medical Care, Medical Products Div., Inc., 1990) after a 90-day review. Its family tree reaches back 1 generation to 1990. It has been recalled once.
- Decided
- Jan 24, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895991 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK895991 Peritoneal Dialysis Drainage Set NO. 48-0025-6National Medical Care, Medical Products Div., Inc. · 1990
- This deviceK173363 Cycler Drain Bag SetFresenius Medical Care Renal Therapies Group, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895991 | Peritoneal Dialysis Drainage Set NO. 48-0025-6 | National Medical Care, Medical Products Div., Inc. | 1990 | — |
| 0 (this device) | K173363 | Cycler Drain Bag Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | — |
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 KDJ? 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 KDJ device
- #1 K250404 stay•safe® catheter extension set with Safe-…score 9.4 · 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 |
|---|---|---|---|
| * | K895991 | Peritoneal Dialysis Drainage Set NO. 48-0025-6Summary page 4…ication Panel: Gastroenterology/Urology 5.3. Legally Marketed Predicate Device The legally marketed predicate device is the Peritoneal Dialysis Drainage Set (K895991). This predicate has not been subject to a design-related recall. 5.4. Device Description 5.4.1. Device Identificati… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2021 | Class II | Z-2083-2021 | Environmental control | Exposed to freezing temperatures due to refrigerated truck malfunctions |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K895991.
How does its category compare?
All KDJ devicesKDJ Set, Administration, For Peritoneal Dialysis, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KDJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDJ
90in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDJ
21in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDJ
2,460in 2025
MAUDE reports naming product code KDJ, 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 | — | 0 | 219 |
| 2008 | 1 | — | 0 | 411 |
| 2009 | 0 | — | 2 | 233 |
| 2010 | 0 | — | 0 | 1,879 |
| 2011 | 0 | — | 0 | 4,315 |
| 2012 | 0 | — | 0 | 4,294 |
| 2013 | 1 | — | 1 | 5,623 |
| 2014 | 0 | — | 0 | 7,680 |
| 2015 | 2 | — | 1 | 6,870 |
| 2016 | 1 | — | 0 | 7,045 |
| 2017 | 0 | — | 0 | 4,636 |
| 2018 | 3 | 90 | 0 | 3,379 |
| 2019 | 1 | — | 0 | 2,456 |
| 2020 | 0 | — | 1 | 2,870 |
| 2021 | 0 | — | 0 | 3,167 |
| 2022 | 1 | — | 12 | 2,927 |
| 2023 | 0 | — | 1 | 2,947 |
| 2024 | 1 | — | 21 (10) | 3,113 |
| 2025 | 1 | — | 0 | 2,460 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cycler Drain Bag Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The Cycler Drain Bag Set is an optional receptacle that connects to the Luer-lock end of a Cycler Set drain line in order to collect patient effluent during PD treatments. This device is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173363 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173363: Cycler Drain Bag Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173363
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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