510(k) · Cleared
ClearedDialguard Endotoxin Removal Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarigen, Inc. · FIP Subsystem, Water Purification
Cleared on Aug 14, 2000 as substantially equivalent to K945136 (Minntech Corp., 1995) after a 279-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Aug 14, 2000
- Review
- 279 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945136 (1995). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K052764Diacap Ultra Dialysis Fluid FilterB. Braun Medizintechnologie GmbH · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945136 | Renaguard Dialysate Filter | Minntech Corp. | 1995 | — |
| 0 (this device) | K993806 | Dialguard Endotoxin Removal Device | Clarigen, Inc. | 2000 | — |
| +1 | K052764 | Diacap Ultra Dialysis Fluid Filter | B. Braun Medizintechnologie GmbH | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 FIP? 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 FIP device
- #1 K251851 DIASAFEplusUS (F00013010)score 14.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K945136 | Renaguard Dialysate FilterSummary page 2…sate and water Classification name: Water Purification Subsystem per 21 CFR 876.5665 Product Code: 78 FIP 3. Predicate Device RenaGuard™ Dialysate Filter 510(k) Number K945136 4. Device Description DialGuard™ is a device used for the reduction of endotoxin from dialysate and water. It consists of a pol… | 1995 |
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 |
|---|---|---|---|
| K052764 | Diacap Ultra Dialysis Fluid Filter | 2006 | 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 FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FIP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIP
77in 2025
MAUDE reports naming product code FIP, 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 | 1 | — | 0 | 1 |
| 2008 | 3 | 202 | 0 | 5 |
| 2009 | 3 | 167 | 0 | 0 |
| 2010 | 2 | — | 0 | 12 |
| 2011 | 4 | 116 | 0 | 4 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 4 | 125 | 0 | 41 |
| 2014 | 4 | 126 | 0 | 34 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 13 |
| 2020 | 1 | — | 1 | 12 |
| 2021 | 1 | — | 0 | 35 |
| 2022 | 1 | — | 0 | 57 |
| 2023 | 3 | 69 | 0 | 140 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 88 | 0 | 77 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DialGuard™ device is intended to be used for the reduction of endotoxin from:
1. Dialysate prior to entering the dialyser
2. Water prior to its use for preparation of dialysate
3. Water prior to use for regenerating dialysers.
DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments. Experimental data indicates that DialGuard ™ will consistently reduce endotoxin levels to € 0.05 EU/mL. (AAMI standard for water for dialysate is < 5.0 EU/mL. Currently, there are no standards set for dialysate).
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/K993806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993806: Dialguard Endotoxin Removal Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993806
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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