510(k) · Cleared
Recalled · Class II · 2016Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Apr 24, 2006 as substantially equivalent to K030592 (Gambro Renal Care Products, 2003) after an 89-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 24, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955592 (1997). 4 ancestors in all, the oldest K902481 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
- 2 generations backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
- 1 generation backK030592 Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 2003
- This deviceK060195 Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single UseGambro Renal Products · 2006
- Descendant · cites it directly · 1 of its ownK072232 Gambro Polyflux Hemodialyzer, Model: HD-C4 SmallGambro Renal Products, Inc. · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK130039 Revaclear 300 Dialyzer, Revaclear 400 DialyzerGambro Renal Products, Inc. · 2013 · 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 |
|---|---|---|---|---|---|
| −3 | K955592 | Cobe Centrysystem 14 Pes Hemodialyzers | Cobe Renal Care, Inc. | 1997 | — |
| −2 | K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters | Gambro Healthcare | 1999 | — |
| −1 | K030592 | Gambro Polyflux, Model 140H, 170H, 210H | Gambro Renal Care Products | 2003 | — |
| 0 (this device) | K060195 | Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single Use | Gambro Renal Products | 2006 | — |
| +1 | K072232 | Gambro Polyflux Hemodialyzer, Model: HD-C4 Small | Gambro Renal Products, Inc. | 2007 | 1 |
| +1 | K130039 | Revaclear 300 Dialyzer, Revaclear 400 Dialyzer | Gambro Renal Products, Inc. | 2013 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 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? (1)
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 |
|---|---|---|---|
| * | K030592 | Gambro Polyflux, Model 140H, 170H, 210HSummary page 1…fication name: High Permeability lH1emodialysis System Accessory (876.5860) Predicate Devices: Polyflux 21011l Hemodialyzer / Filter K030592 Device Description: This device is intended for use in hemodialysis for the treatment of acute and chronic renal failure. The… | 2003 |
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 |
|---|---|---|---|---|
| Oct 12, 2016 | Class II | Z-0370-2017 | Process control | Potential presence of particulate matter on the blood side of the dialyzer |
| Apr 16, 2014 | Class II | Z-1644-2014 | Storage | The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072232 (Gambro Renal Products, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K030592.
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 capillary dialyzer is intended for hemodialysis for the treatment of chronic and acute renal failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060195: Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060195
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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