510(k) · Cleared
Recalled · Class II · 2021Prismaflex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jun 17, 2011 as substantially equivalent to K062090 (Gambro Renal Products, 2006) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Jun 17, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 1 generation to K062090 (2006). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062090 | Prisma System R03.10A | Gambro Renal Products | 2006 | — |
| 0 (this device) | K110823 | Prismaflex | Gambro Renal Products, Inc. | 2011 | — |
| +1 | K170790 | SAM CRRT Unit, SAM Cassette CRRT | Spectral Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K062090 | Prisma System R03.10ASummary page 2…e Device Information (1) Name of the Device Prisma System R 03.I1OA Catalogue Number: 018089-507 510(k) Number: K062090 Classification Name High Permeability Hemodialysis System Device Class 11 Product… | 2006 |
| * | K072093 | Prismaflex System, Version 3.20Summary page 2…cate Device Information (2) Name of the Device Prismaf'lex® System 3.20 Catalogue Number: 107493 510(k) Number: K072093 Classification Name High Permeability Hemodialysis System Device Class 11 Product… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170790 | SAM CRRT Unit, SAM Cassette CRRT | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2021 | Class II | Z-1278-2021 | Process control | Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test. |
| Feb 6, 2020 | Class II | Z-1829-2020 | Under Investigation by firm | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| Feb 6, 2020 | Class II | Z-1832-2020 | Under Investigation by firm | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| Feb 6, 2020 | Class II | Z-1833-2020 | Under Investigation by firm | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| Feb 6, 2020 | Class II | Z-1828-2020 | Under Investigation by firm | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| Feb 6, 2020 | Class II | Z-1830-2020 | Under Investigation by firm | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| Feb 6, 2020 | Class II | Z-1831-2020 | Under Investigation by firm | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| Apr 24, 2018 | Class II | Z-1923-2018 | Software design | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a… |
| Feb 15, 2017 | Class II | Z-1280-2018 | Use error | Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the… |
The 5 latest of 9 recalls; the web page lists all.
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, K170790 (Spectral Medical, Inc., 2017) 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. 2011, this device’s year, is highlighted.
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 Prismaflex® control unit is intended for:
* Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
* Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
All treatments administered via the Prismaflex® control unit must be prescribed by a physician
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/K110823 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110823: Prismaflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110823
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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