510(k) · Cleared
ClearedMiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Cleared on Mar 12, 2024 as substantially equivalent to K152675 (Baxter Healthcare, 2015) after a 263-day review. Its family tree reaches back 2 generations to 1988. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 12, 2024
- Review
- 263 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K882498 (1988). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK882498 Extended Life Capd Transfer Set 5C4444Baxter Healthcare Corp · 1988 · Recalled
- 1 generation backK152675 Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium…Baxter Healthcare · 2015 · Recalled (Class I)
- This deviceK231849 MiniCap Extended Life PD Transfer Set with Twist Clamp - Code…Baxter Healthcare · 2024
Class I recalls in this family
- K152675 Extended Life Capd Transfer Set, Peritoneal…direct predicate · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882498 | Extended Life Capd Transfer Set 5C4444 | Baxter Healthcare Corp | 1988 | 7 |
| −1 | K152675 | Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter… | Baxter Healthcare | 2015 | Class I |
| 0 (this device) | K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap… | Baxter Healthcare | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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.
1 device in this family has a Class I recall. 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
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 |
|---|---|---|---|
| * | K152675 | Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and…Summary page 6…Device(s) Device Company Predicate 510(k) Clearance Date MiniCap Extended Life Baxter Healthcare K152675 10/29/2015 PD Transfer Sets Corporation DESCRIPTION OF THE DEVICE: The MiniCap Extended Life PD… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K152675Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium…Baxter Healthcare · 2015 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 2 companies; a new generation was cleared every 27.3 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K152675.
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. 2024, 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?
These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231849: MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231849
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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