510(k) · Cleared
ClearedHigh Permeability Dialyer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minntech Corp. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Feb 18, 1994 after a 591-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Feb 18, 1994
- Review
- 591 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK923312 High Permeability DialyerMinntech Corp. · 1994
- Descendant · cites it directly · 7 of its ownK014152 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2002
- Descendant · 2 generations on · 6 of its ownK032356 Nxstage System One with Cartridge ExpressNxstage Medical, Inc. · 2003
- Descendant · 3 generations on · 5 of its ownK050727 Modification to Nxstage Cartridge ExpressNxstage Medical, Inc. · 2005
- Descendant · 4 generations on · 4 of its ownK061837 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2006 · Recalled
- Descendant · 5 generations on · 0 of its ownK232803 NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K014152Nxstage Cartridge ExpressNxstage Medical, Inc. · 2002 · cites it directly7descendants
- K032356Nxstage System One with Cartridge ExpressNxstage Medical, Inc. · 2003 · 2 generations on6descendants
- K050727Modification to Nxstage Cartridge ExpressNxstage Medical, Inc. · 2005 · 3 generations on5descendants
- K061837Nxstage Cartridge ExpressNxstage Medical, Inc. · 2006 · 4 generations on4descendants
- K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc. · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923312 | High Permeability Dialyer | Minntech Corp. | 1994 | — |
| +1 | K014152 | Nxstage Cartridge Express | Nxstage Medical, Inc. | 2002 | — |
| +2 | K032356 | Nxstage System One with Cartridge Express | Nxstage Medical, Inc. | 2003 | — |
| +3 | K050727 | Modification to Nxstage Cartridge Express | Nxstage Medical, Inc. | 2005 | — |
| +4 | K061837 | Nxstage Cartridge Express | Nxstage Medical, Inc. | 2006 | 1 |
| +5 | K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | Nxstage Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K014152 (Nxstage Medical, Inc., 2002) has gone furthest, with 7 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.
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 | — |
https://510kreport.com/device/K923312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923312: High Permeability Dialyer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923312
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026