510(k) · Cleared
ClearedUltracon Ultrafiltrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantic Biomedical, Inc. · FJI Dialyzer, Capillary, Hollow Fiber
Cleared on Feb 27, 1998 as substantially equivalent to K945620 (Althin Medical AB an Affiliate of Baxter Intl, 1995) after a 295-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Feb 27, 1998
- Review
- 295 days
- Class
- Class II
- Product code
- FJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945620 (1995). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K981253Ultracon UltrafiltratorInterpore Intl. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945620 | Altra Flux (TM) 140 Hemodialyzer | Althin Medical AB an Affiliate of Baxter Intl | 1995 | — |
| 0 (this device) | K971710 | Ultracon Ultrafiltrator | Quantic Biomedical, Inc. | 1998 | — |
| +1 | K981253 | Ultracon Ultrafiltrator | Interpore Intl. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 FJI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K945620 | Altra Flux (TM) 140 HemodialyzerSummary page 1…Ultrafiltrator Proprietary Name: UltraCon™ Ultrafiltrator PREDICATE DEVICES Predicate Device 1; Altra FLUX™ 140 Hemodialyzer, Althin Medical, Inc. Reference Number K945620/A. Predicate Device 2; Minifilter™ Hemofilter, Amicon Division, WR Grace & Co. Reference Number unknown. Predicate Device 3; H… | 1995 |
| * | — | Minifilter™ Hemofilter Named without a submission number | |
| * | — | Hemocor HPH™ 400 Hemoconcentrator Named without a submission number |
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 |
|---|---|---|---|
| K981253 | Ultracon Ultrafiltrator | 1998 | 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?
How does its category compare?
All FJI devicesFJI Dialyzer, Capillary, Hollow Fiber: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FJI
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · FJI
Too few FJI 510(k)s in any year since 2007 to give a median.
Recalls per year · FJI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FJI
145in 2025
MAUDE reports naming product code FJI, 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 | 0 | — | 0 | 17 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 32 |
| 2011 | 0 | — | 0 | 47 |
| 2012 | 0 | — | 0 | 211 |
| 2013 | 1 | — | 0 | 553 |
| 2014 | 0 | — | 0 | 633 |
| 2015 | 0 | — | 0 | 561 |
| 2016 | 0 | — | 0 | 562 |
| 2017 | 0 | — | 0 | 182 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 51 |
| 2024 | 0 | — | 0 | 152 |
| 2025 | 0 | — | 1 | 145 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UltraCon™ Ultrafiltrator is indicated for use as an ultrafiltrator for the selective removal of undesireable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971710 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971710: Ultracon Ultrafiltrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971710
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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