510(k) · Cleared

Recalled · Class II · 2013

Diacap Ultra Dialysis Fluid Filter

K052764510(k) TraditionalCleared Jun 9, 2006252-day reviewClass II21 CFR 876.5820Recalls 1

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

B. Braun Medizintechnologie GmbH · FKQ System, Dialysate Delivery, Central Multiple Patient

Cleared on Jun 9, 2006 as substantially equivalent to K993806 (Clarigen, Inc., 2000) and 2 other predicates after a 252-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.

Decided: Jun 9, 2006
Review: 252 days
Class: Class II
Product code: FKQ
Recalls: 1
Predicates: 3

Its longest line of descent runs back 2 generations to K945136 (1995). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK945136 Renaguard Dialysate FilterMinntech Corp. · 1995
1 generation backK993806 Dialguard Endotoxin Removal DeviceClarigen, Inc. · 2000
This deviceK052764 Diacap Ultra Dialysis Fluid FilterB. Braun Medizintechnologie GmbH · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K945136	Renaguard Dialysate Filter	Minntech Corp.	1995	—
−1	K993806	Dialguard Endotoxin Removal Device	Clarigen, Inc.	2000	—
0 (this device)	K052764	Diacap Ultra Dialysis Fluid Filter	B. Braun Medizintechnologie GmbH	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0

FIG. 1 — Lineage of K052764, 1995–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FKQ? 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

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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	Applicant	Decided	Recalls
*	K993806	Dialguard Endotoxin Removal Device Summary page 1 …Class 1I, 21 CFR §876.5820, System, Dialysate Delivery, Single CLASSIFICATION: Patient, Product Code: FKP PREDICATE DEVICE: K993806 Clarigen, Inc., DialGuardTM K003957 GAMBRO®& Renal Products, DialclearTM Ultrafilter…	Clarigen, Inc.	2000	—
*	K003957	Diaclear Ultrafilter Summary page 1 …elivery, Single CLASSIFICATION: Patient, Product Code: FKP PREDICATE DEVICE: K993806 Clarigen, Inc., DialGuardTM K003957 GAMBRO®& Renal Products, DialclearTM Ultrafilter K983 126 Minntech FibreFlo DESCRIPTION:…	Gambro Renal Products	2001	—
*	K983126	Fiberflo Hollow Fiber Capsule Water Filters Summary page 1 …K993806 Clarigen, Inc., DialGuardTM K003957 GAMBRO®& Renal Products, DialclearTM Ultrafilter K983 126 Minntech FibreFlo DESCRIPTION: The Diacap Ultra dialysis fluid filter is sterile, non-pyrogenic dialysis…	Minntech Corp.	1999	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 1, 2013	Class II	Z-1183-2013	Process design	There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
None of the 4 ancestors has a recall.

How does its category compare?

All FKQ devices

FKQ System, Dialysate Delivery, Central Multiple Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKQ

FDA has decided no FKQ device since 2007.

Median 510(k) review, days · FKQ

Too few FKQ 510(k)s in any year since 2007 to give a median.

Recalls per year · FKQ

No recall names FKQ since 2007.

Adverse event reports per year · FKQ

6in 2024

2007high 6 (2024) · low 0 (2007)2025

MAUDE reports naming product code FKQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	1
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	1
2020	—	0
2021	—	2
2022	—	0
2023	—	3
2024	—	6
2025	—	0
2026	—	—

What is it indicated for?

The Diacap Ultra Dialysis Fluid Filter is intended to filter bacteria and endotoxins from dialysate.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052764 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052764: Diacap Ultra Dialysis Fluid Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052764

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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