510(k) · Cleared
ClearedDHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6 Hemoconcentrator: Dideco Pediatric/Small Adult
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dideco S.P.A. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Nov 4, 2002 as substantially equivalent to K003023 (Hospal Industrie, 2001) and 1 other predicate after a 164-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Nov 4, 2002
- Review
- 164 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923139 (1994). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923139 Hemocor HP Hemoconcentrator SeriesMinntech Corp. · 1994 · Recalled
- This deviceK021732 DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR…Dideco S.P.A. · 2002
- Descendant · cites it directly · 1 of its ownK081313 SH14 HemoconcentratorSorin Group Italia S.R.L. · 2008
- Descendant · cites it directly · 0 of its ownK243264 DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF…Sorin Group Italia S.R.L. · 2025
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 | K923139 | Hemocor HP Hemoconcentrator Series | Minntech Corp. | 1994 | 1 |
| 0 (this device) | 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 | — |
| +1 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K003023 | Cobe HC 700 Midi HemoconcentratorSummary page 1…y With or Without Sealed Dialysate System PREDICATE DEVICE: Cobe HC 700 Midi Hemoconcentrator (K003023) Hernocor HPH 400 Hernoconcentrator (K923139) DEVICE DESCRIPTION: The Dideco DHF… | 2001 |
| * | K923139 | Hemocor HP Hemoconcentrator SeriesSummary page 1…EDICATE DEVICE: Cobe HC 700 Midi Hemoconcentrator (K003023) Hernocor HPH 400 Hernoconcentrator (K923139) DEVICE DESCRIPTION: The Dideco DHF Hernoconcentrator is a hollow fiber type hernoconcentrator consisting of an external transp… | 1994 |
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)
No FDA recall names this device.
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, K081313 (Sorin Group Italia S.R.L., 2008) has gone furthest, with 1 descendant 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 Dideco DHF Hernoconcentrator is intended for use in cardiopulmonary bypass circuits for
hemoconcentration and consequent restoring of patient's physiological hematocrit The choice of
hemconcentrator 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/K021732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021732: DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6 Hemoconcentrator: Dideco Pediatric/Small Adult.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021732
Report an extraction error
Are you the manufacturer?
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