510(k) · Cleared
Recalled · 2010Heomdialysis Single Patient System (SPS) Model 650
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FKP System, Dialysate Delivery, Single Patient
Cleared on Feb 8, 1989 after a 198-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 8, 1989
- Review
- 198 days
- Class
- Class II
- Product code
- FKP
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK883111 Heomdialysis Single Patient System (SPS) Model 650Baxter Healthcare Corp · 1989
- Descendant · cites it directly · 2 of its ownK992894 Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corp · 1999 · Recalled
- Descendant · 2 generations on · 0 of its ownK053539 Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corporation · 2006
- Descendant · 2 generations on · 0 of its ownK013562 Aurora System 1000 Series Home Self-Care Single Patient Delivery…Baxter Healthcare Corp · 2002 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K992894Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corp · 1999 · cites it directly2descendants
- K053539Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corporation · 2006 · 2 generations on0descendants
- K013562Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys…Baxter Healthcare Corp · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883111 | Heomdialysis Single Patient System (SPS) Model 650 | Baxter Healthcare Corp | 1989 | — |
| +1 | K992894 | Meridian Hemodialysis Machine, Model 5M5576 | Baxter Healthcare Corp | 1999 | 5 |
| +2 | K053539 | Meridian Hemodialysis Machine, Model 5M5576 | Baxter Healthcare Corporation | 2006 | — |
| +2 | K013562 | Aurora System 1000 Series Home Self-Care Single Patient Delivery System… | Baxter Healthcare Corp | 2002 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FKP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992894 | Meridian Hemodialysis Machine, Model 5M5576 | 1999 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2010 | Not classified | Z-1322-2010 | Software change control | Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software. |
| Feb 20, 2003 | Not classified | Z-0661-03 | Other | Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K992894 (Baxter Healthcare Corp, 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FKP devicesFKP System, Dialysate Delivery, Single Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FKP
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · FKP
Too few FKP 510(k)s in any year since 2007 to give a median.
Recalls per year · FKP
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FKP
4in 2021
MAUDE reports naming product code FKP, 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 | 8 |
| 2008 | 0 | — | 4 | 26 |
| 2009 | 0 | — | 2 | 22 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K883111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883111: Heomdialysis Single Patient System (SPS) Model 650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883111
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026