510(k) · Cleared
ClearedDHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Apr 25, 2025 as substantially equivalent to K021732 (Dideco S.P.A., 2002) and 1 other predicate after a 192-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 25, 2025
- Review
- 192 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923139 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK923139 Hemocor HP Hemoconcentrator SeriesMinntech Corp. · 1994 · Recalled
- 2 generations backK021732 DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR…Dideco S.P.A. · 2002
- 1 generation backK081313 SH14 HemoconcentratorSorin Group Italia S.R.L. · 2008
- This deviceK243264 DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF…Sorin Group Italia S.R.L. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923139 | Hemocor HP Hemoconcentrator Series | Minntech Corp. | 1994 | 1 |
| −2 | K021732 | DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6… | Dideco S.P.A. | 2002 | — |
| −1 | K081313 | SH14 Hemoconcentrator | Sorin Group Italia S.R.L. | 2008 | — |
| 0 (this device) | K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14… | Sorin Group Italia S.R.L. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K021732 | DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6…Summary page 6…ified and unmodified models have the same fundamental scientific technology and intended use: 510(k) Number: K021732 Device Trade Name: Dideco DHF hemoconcentrators… | 2002 |
| * | K081313 | SH14 HemoconcentratorSummary page 6…Class II Classification Panel: Gastroenterology & urology 510(k) Number: K081313 Device Trade Name: SH 14 hemoconcentrators Cla… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K021732.
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. 2025, 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 hemoconcentrators are intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient physiological hematocrit. The choice of hemoconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243264: DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243264
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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