510(k) · Cleared

Recalled · 2003

Toraysulfone Dialyzer

K002512510(k) TraditionalCleared Oct 15, 2001426-day reviewClass II21 CFR 876.5860Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Toray Industries (America), Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Oct 15, 2001 after a 426-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided: Oct 15, 2001
Review: 426 days
Class: Class II
Product code: KDI
Recalls: 1
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK002512 Toraysulfone DialyzerToray Industries (America), Inc. · 2001
Descendant · cites it directly · 0 of its ownK030050 Toraysulfone Dialyzer, BS-L SeriesToray Industries (America), Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K030050Toraysulfone Dialyzer, BS-L SeriesToray Industries (America), Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002512	Toraysulfone Dialyzer	Toray Industries (America), Inc.	2001	—
+1	K030050	Toraysulfone Dialyzer, BS-L Series	Toray Industries (America), Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K002512, 2001–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030050	Toraysulfone Dialyzer, BS-L Series	Toray Industries (America), Inc.	2003	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-0352-04	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, K030050 (Toray Industries (America), Inc., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KDI devices

KDI 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

2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007high 6,154 (2014) · low 522 (2009)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/K002512 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002512: Toraysulfone Dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002512

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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