Homechoice APD SET
Homechoice APD SET With Cassette AND 4 Prong Spike
1manufacturer
1catalogue number
2recalls on this code
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Viant Medical Suzhou EPZ Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Vantive US Healthcare LLC, United States |
|---|---|
| FDA product code | FKX |
| Device type | System, Peritoneal, Automatic Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5630 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K923065 |
| Record published | 2025-10-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store at room temperature. |
| Packaging | Case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5C4469C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sharesource Connectivity Platform | Baxter Healthcare Corporation | 7 |
| Peritoneal Dialysis | Merit Medical Systems, Inc. | 6 |
| Liberty® | Fresenius Medical Care | 5 |
| VersiPD | Fresenius Medical Care | 4 |
| VersiPD | Fresenius USA, Inc. | 3 |
| Liberty® PDx | Fresenius Medical Care | 3 |
| Liberty | Fresenius Medical Care Renal Therapies Group, LLC | 2 |
| Premier | Fresenius Medical Care | 2 |
| Safe-Lock® | Fresenius Medical Care | 2 |
| HomeChoice APD System | Baxter Healthcare Corporation | 2 |
| LOW Recirculation Volume APD SET | Baxter Healthcare Corporation | 2 |
| Sharesource | Baxter Healthcare Corporation | 2 |
Showing 12 of 38. All products under System, Peritoneal, Automatic Delivery
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Baxter Healthcare Renal Div | 510(k) number | 2012-07-06 | Class II | Employee error | Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette. | N/A | 2012-10-15 |
| Baxter Healthcare Renal Div | 510(k) number | 2007-11-20 | Not classified | Device Design | Unrecorded Infusion; If the system is powered down or a power failure occurs during a fill cycle, the HomeChoice system may not record the last 1-4 pump strokes infused into the patient when the power is restored. This situation may create | 71,261 units | 2009-10-26 |
| Baxter Healthcare Renal Div | 510(k) number | 2005-06-21 | Not classified | Other | The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device’s ground system, posing an electric shock hazard. | 52,617 units | 2007-12-11 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-08-28 | Class II | Software design | Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their ther | 1 | |
| 2017-09-01 | Class II | Equipment maintenance | The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette. | 164,700 units | 2019-08-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.