510(k) · Cleared
Recalled · 2006Meridian Hemodialysis Machine, Model 5M5576
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Nov 24, 1999 as substantially equivalent to K883111 (Baxter Healthcare Corp, 1989) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 24, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883111 (1989). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK883111 Heomdialysis Single Patient System (SPS) Model 650Baxter Healthcare Corp · 1989 · Recalled
- This deviceK992894 Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corp · 1999
- Descendant · cites it directly · 0 of its ownK053539 Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corporation · 2006
- Descendant · cites it directly · 0 of its ownK013562 Aurora System 1000 Series Home Self-Care Single Patient Delivery…Baxter Healthcare Corp · 2002 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883111 | Heomdialysis Single Patient System (SPS) Model 650 | Baxter Healthcare Corp | 1989 | 2 |
| 0 (this device) | K992894 | Meridian Hemodialysis Machine, Model 5M5576 | Baxter Healthcare Corp | 1999 | — |
| +1 | K053539 | Meridian Hemodialysis Machine, Model 5M5576 | Baxter Healthcare Corporation | 2006 | — |
| +1 | K013562 | Aurora System 1000 Series Home Self-Care Single Patient Delivery System… | Baxter Healthcare Corp | 2002 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 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 KDI? 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 KDI device
- #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K883111 | Heomdialysis Single Patient System (SPS) Model 650Summary page 1…lity Hemodialysis System (per 21CFR 867.5860) Substantially equivalent devices Baxter 1550 Hemodialysis Machine and the 1550, Single Needle Patient System [510(k) number K883111 and K922757, respectively] Description of the device The Baxter Meridian is a single patient hemodialysis instrument that prepar… | 1989 |
| * | K922757 | SPS 1550 Single Needle Patient SystemSummary page 1…lysis System (per 21CFR 867.5860) Substantially equivalent devices Baxter 1550 Hemodialysis Machine and the 1550, Single Needle Patient System [510(k) number K883111 and K922757, respectively] Description of the device The Baxter Meridian is a single patient hemodialysis instrument that prepares dialysis… | 1995 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2006 | Not classified | Z-0169-2007 | Other | The Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring. |
| Sep 28, 2005 | Not classified | Z-0275-06 | Other | Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a death and a serious injury. |
| Dec 2, 2004 | Not classified | Z-0299-05 | Other | The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard. |
| Mar 10, 2004 | Not classified | Z-0758-04 | Other | Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian. |
| Oct 3, 2003 | Not classified | Z-0947-05 | Other | The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K053539 (Baxter Healthcare Corporation, 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KDI devicesKDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDI
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 2025
MAUDE reports naming product code KDI, 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 | 11 | 91 | 4 | 916 |
| 2008 | 6 | 148 | 0 | 1,042 |
| 2009 | 4 | 236 | 3 | 522 |
| 2010 | 9 | 186 | 1 | 823 |
| 2011 | 5 | 85 | 4 | 2,270 |
| 2012 | 6 | 153 | 1 | 1,765 |
| 2013 | 11 | 247 | 2 | 2,360 |
| 2014 | 8 | 164 | 3 | 6,154 |
| 2015 | 5 | 69 | 5 | 4,182 |
| 2016 | 5 | 230 | 4 | 766 |
| 2017 | 8 | 188 | 1 | 963 |
| 2018 | 2 | — | 1 | 1,716 |
| 2019 | 4 | 263 | 6 | 1,587 |
| 2020 | 9 | 266 | 0 | 1,633 |
| 2021 | 2 | — | 2 | 1,944 |
| 2022 | 7 | 259 | 17 | 2,180 |
| 2023 | 7 | 157 | 8 (8) | 2,692 |
| 2024 | 7 | 235 | 4 (2) | 2,441 |
| 2025 | 9 | 199 | 2 | 2,786 |
| 2026 | 6 | 154 | 2 | — |
What is it indicated for?
The Baxter Meridian machine is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient’s blood, an extracorporeal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic…
Read the full statement (105 words)
The Baxter Meridian machine is part of a high permeability hemodialysis system which
consists of a controlled dialysate delivery system that incorporates an ultrafiltration
controller to prevent excessive loss of water from the patient’s blood, an extracorporeal
blood set and a high permeability dialyzer. The standard features of the Meridian
machine include high blood flow rate capacity (for shortened hemodialysis treatment
time), automatic ultrafiltration control. standard and variable bicarbonate and sodium
capabilities and automated chemical disinfection, The Meridian machine will operate in
either the bicarbonate or acetate mode for concentrates,
The Meridian Hemodialysis Machine is designed to operate in the chronic and acute
dialysis environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992894: Meridian Hemodialysis Machine, Model 5M5576.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992894
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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