510(k) · Cleared
Recalled · 2003Filtryzer (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toray Industries (America), Inc. · FJI Dialyzer, Capillary, Hollow Fiber
Cleared on May 19, 1995 after a 550-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 19, 1995
- Review
- 550 days
- Class
- Class II
- Product code
- FJI
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK935471 Filtryzer (TM)Toray Industries (America), Inc. · 1995
- Descendant · cites it directly · 0 of its ownK994198 Hemofeel-CH, Models CH-0.35L, CH-0.6L, CH-1.0LToray Industries (America), Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K994198Hemofeel-CH, Models CH-0.35L, CH-0.6L, CH-1.0LToray Industries (America), Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935471 | Filtryzer (TM) | Toray Industries (America), Inc. | 1995 | — |
| +1 | K994198 | Hemofeel-CH, Models CH-0.35L, CH-0.6L, CH-1.0L | Toray Industries (America), Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K994198 | Hemofeel-CH, Models CH-0.35L, CH-0.6L, CH-1.0L | 2000 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 30, 2003 | Not classified | Z-0349-04 | Other | Potential loose header (end cap) on hollow fiber dialyzers. |
| Dec 30, 2003 | Not classified | Z-0351-04 | Other | Potential loose header (end cap) on hollow fiber dialyzers. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K994198 (Toray Industries (America), Inc., 2000) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K935471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935471: Filtryzer (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935471
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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