510(k) · Cleared
ClearedHF Junior Hemofilter
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 Aug 8, 2007 as substantially equivalent to K962707 (Minntech Corp., 1996) and 1 other predicate after a 91-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Aug 8, 2007
- Review
- 91 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K980859 (1998). 3 ancestors in all, the oldest K962707 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK980859 Hemocor HPH Mini HemoconcentratorMinntech Corp. · 1998
- 1 generation backK050952 HPH Junior High Performance HemoconcentratorMinntech Corp. · 2006
- This deviceK071298 HF Junior HemofilterMinntech Corp. · 2007
- Descendant · cites it directly · 0 of its ownK123395 Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K123395Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980859 | Hemocor HPH Mini Hemoconcentrator | Minntech Corp. | 1998 | — |
| −1 | K050952 | HPH Junior High Performance Hemoconcentrator | Minntech Corp. | 2006 | — |
| 0 (this device) | K071298 | HF Junior Hemofilter | Minntech Corp. | 2007 | — |
| +1 | K123395 | Nxstage System One Low Volume Cartridge Express | Nxstage Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K962707 | Minntech Minnifilter Plus Hemofilter and Tubing SetSummary page 2…tates The HF Junior is equivalent in materials and performance to other hemofilters manufactured by Minntech, including the HF Minifilter Plus Hemofilter (K962707) cleared for market in October 1996. The only difference between the HF Junior and the HF Minifilter is that the HF… | 1996 |
| * | K050952 | HPH Junior High Performance HemoconcentratorSummary page 2…xactly the same for all of the HF devices. In addition to the HF Mini, the HF Junior is identical in configuration, size, and materials to the HPH Junior (K050952) cleared in January 2006. This equivalence has been shown though functional and safety testing as required by the… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123395 | Nxstage System One Low Volume Cartridge Express | 2013 | 0 |
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 9 years and passes through 1 company; a new generation was cleared every 7.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K123395 (Nxstage Medical, Inc., 2013) has gone furthest, with 0 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. 2007, 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 HF Junior Hemoconcentrator is intended for use in prevention or relief of fluid overload, electrolyte and acid imbalances in cases of acute renal failure with oliguria or anuria. Also, it is used to remove excess fluid in cases of congestive heart failure, pulmonary and cerebral edema, anasarca, ascites, septic shock, bums, etc. In hypervolemic patients requiring parenteral nutrition and/or large volume of medications, the hemofilter may be used to…
Read the full statement (126 words)
The HF Junior Hemoconcentrator is intended for use in prevention or relief of fluid overload, electrolyte and acid imbalances in cases of acute renal failure with oliguria or anuria. Also, it is used to remove excess fluid in cases of congestive heart failure, pulmonary and cerebral edema, anasarca, ascites, septic shock, bums, etc. In hypervolemic patients requiring parenteral nutrition and/or large volume of medications, the hemofilter may be used to reduce fluid overload. In hypercatabolic patients requiring more intensive solute removal, a sterile dialysate fluid may be made to flow around the fibers via the dialysate ports in order to increase the clearance of small molecules. It is indicated for patients (including pediatric patients) according to physician assessment of the patient and the instructions for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071298: HF Junior Hemofilter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071298
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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