510(k) · Cleared
Recalled · 2003Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Cleared on Nov 20, 2003 as substantially equivalent to K923065 (Baxter Healthcare Corp, 1994) and 3 other predicates after a 174-day review. Its family tree reaches back 2 generations to 1990. It has been recalled 2 times.
- Decided
- Nov 20, 2003
- Review
- 174 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 2 generations to K895631 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK895631 Disconnect Caps Product Codes 5C4212 and 5C4466Baxter Healthcare Corp · 1990 · Recalled
- 1 generation backK972579 High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose…Baxter Healthcare Corp · 1997
- This deviceK031676 Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q…Baxter Healthcare Corp · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895631 | Disconnect Caps Product Codes 5C4212 and 5C4466 | Baxter Healthcare Corp | 1990 | 4 |
| −1 | K972579 | High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose… | Baxter Healthcare Corp | 1997 | — |
| 0 (this device) | K031676 | Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q, 5C4531Q… | Baxter Healthcare Corp | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 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 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? (4)
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 |
|---|---|---|---|
| * | K923065 | Baxter Personal Cycler Autommated Peritoneal DialSummary page 1…sis, Disposable ClassificationName: Peritoneal Dialysis System and Accessories 21 CFR 876.5630 Equivalent Predicate: HomeChoice APD Set (Baxter Healthcare Corp., K923065), HomeChoice Low Recirculation Volume APD Set (Baxter Healthcare Corp., K012988),… | 1994 |
| * | K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471…Summary page 1…eChoice APD Set (Baxter Healthcare Corp., K923065), HomeChoice Low Recirculation Volume APD Set (Baxter Healthcare Corp., K012988), High Dose Disconnect Cap and MiniCap with Povidone Iodine (Baxter Healthcare Corp.,… | 2001 |
| * | K972579 | High Dose Disconnect Cap and Minicap with Povidone-Iodine, High Dose Disconnect Cap with…Summary page 1…Healthcare Corp., K012988), High Dose Disconnect Cap and MiniCap with Povidone Iodine (Baxter Healthcare Corp., K972579) and Disconnect Caps with Povidone Iodine (Baxter Healthcare Corp., K89563 1) Device Description: Ho… | 1997 |
| * | K895631 | Disconnect Caps Product Codes 5C4212 and 5C4466Summary page 1…ith Povidone Iodine (Baxter Healthcare Corp., K972579) and Disconnect Caps with Povidone Iodine (Baxter Healthcare Corp., K89563 1) Device Description: HomeChoice APD Set with Lineo Connector is a disposable tubing administration s… | 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 |
|---|---|---|---|---|
| Dec 5, 2003 | Not classified | Z-0340-04 | Other | Reports of loosening of the connections and disconnection of the device. |
| Dec 5, 2003 | Not classified | Z-0341-04 | Other | Reports of loosening of the connections and disconnection of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 7.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 5 other devices also cite its predicate K923065.
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.
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 HomeChoice Integrated APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set. The Homechoice Low Recirculation Volume APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy in pediatric and adult…
Read the full statement (172 words)
The HomeChoice Integrated APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.
The Homechoice Low Recirculation Volume APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy in pediatric and adult renal failure patients requiring fill volumes of 60 - 1000 ml, using only the Homechoice Automated Personal Cycler with Low Fill Mode Drain Logic.
The Lineo OptiCap is for protection of the Lineo Connector (patient line) of APD Disposable Sets with Lineo Connector that are intended for delivery of peritoneal dialysis therapy.
The Homechoice Automated PD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the Homechoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031676: Homechoice Apd Set with Lineo Connector, Models 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031676
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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