510(k) · Cleared
Recalled · Class II · 2022Revaclear 300 Dialyzer, Revaclear 400 Dialyzer
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 May 2, 2013 as substantially equivalent to K060195 (Gambro Renal Products, 2006) and 1 other predicate after a 115-day review. Its family tree reaches back 5 generations to 1997. It has been recalled 7 times.
- Decided
- May 2, 2013
- Review
- 115 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 5 generations to K955592 (1997). 6 ancestors in all, the oldest K902481 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
- 4 generations backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
- 3 generations backK030592 Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 2003
- 2 generations backK060195 Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single UseGambro Renal Products · 2006 · Recalled
- 1 generation backK072232 Gambro Polyflux Hemodialyzer, Model: HD-C4 SmallGambro Renal Products, Inc. · 2007 · Recalled
- This deviceK130039 Revaclear 300 Dialyzer, Revaclear 400 DialyzerGambro Renal Products, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K955592 | Cobe Centrysystem 14 Pes Hemodialyzers | Cobe Renal Care, Inc. | 1997 | — |
| −4 | K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters | Gambro Healthcare | 1999 | — |
| −3 | K030592 | Gambro Polyflux, Model 140H, 170H, 210H | Gambro Renal Care Products | 2003 | — |
| −2 | K060195 | Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single Use | Gambro Renal Products | 2006 | 2 |
| −1 | K072232 | Gambro Polyflux Hemodialyzer, Model: HD-C4 Small | Gambro Renal Products, Inc. | 2007 | 1 |
| 0 (this device) | K130039 | Revaclear 300 Dialyzer, Revaclear 400 Dialyzer | Gambro Renal Products, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 |
|---|---|---|---|
| * | K060195 | Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single UseSummary page 1…KDI Review Panel: Gastroenterology / Urology Predicate Devices: Polyflux HD-C4 (BIG) (Revaclear Max) Cleared - April 24, 2006 K060 195 Polyflux HD-C4 (Small) (Revaclear) Cleared - September 7, 2007 K(072232 Device Description: This device is intend… | 2006 |
| * | K072232 | Gambro Polyflux Hemodialyzer, Model: HD-C4 SmallSummary page 1…s: Polyflux HD-C4 (BIG) (Revaclear Max) Cleared - April 24, 2006 K060 195 Polyflux HD-C4 (Small) (Revaclear) Cleared - September 7, 2007 K(072232 Device Description: This device is intended for the treatment of chronic and acute renal failure by hemodialysis. The intended p… | 2007 |
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 |
|---|---|---|---|---|
| Nov 23, 2022 | Class II | Z-0760-2023 | Process change control | Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer |
| Nov 23, 2022 | Class II | Z-0763-2023 | Process control | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak |
| Nov 23, 2022 | Class II | Z-0764-2023 | Process control | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak |
| Nov 23, 2022 | Class II | Z-0762-2023 | Process control | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak |
| Nov 15, 2019 | Class II | Z-1409-2020 | Process control | There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer. |
| May 31, 2019 | Class II | Z-1908-2019 | Process control | There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. |
| May 31, 2019 | Class II | Z-1909-2019 | Process control | There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K060195.
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. 2013, 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?
Revaclear 300 and 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130039: Revaclear 300 Dialyzer, Revaclear 400 Dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130039
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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