510(k) · Cleared
ClearedCkhemo, Model Ckhemo Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Csam, Inc. · FKP System, Dialysate Delivery, Single Patient
Cleared on Nov 30, 1999 after a 147-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 30, 1999
- Review
- 147 days
- Class
- Class II
- Product code
- FKP
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FKP? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All FKP devicesFKP System, Dialysate Delivery, Single Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FKP
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · FKP
Too few FKP 510(k)s in any year since 2007 to give a median.
Recalls per year · FKP
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FKP
4in 2021
MAUDE reports naming product code FKP, 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 | 8 |
| 2008 | 0 | — | 4 | 26 |
| 2009 | 0 | — | 2 | 22 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate total urea clearance (Kt/V), total urea clearance (Kt/V) delivered using the natural log formula, residual renal urea clearance (KrU), normalized protein catabolic rate (NPCR), actual blood flow, urea reduction ratio, body water volume calculated by urea kinetic modeling, total body water volume calculated using Watson's formula, actual weight loss after…
Read the full statement (134 words)
The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate total urea clearance (Kt/V), total urea clearance (Kt/V) delivered using the natural log formula, residual renal urea clearance (KrU), normalized protein catabolic rate (NPCR), actual blood flow, urea reduction ratio, body water volume calculated by urea kinetic modeling, total body water volume calculated using Watson's formula, actual weight loss after treatment, percent deviation (%Dev), and treatment time. These values are calculated using the test results of blood drawn immediately prior to and upon completion of kidney hemodialysis treatment based on the existing scientific formulas for single pool urea kinetic modeling. The device software is not meant to serve as the sole tool for determining effectiveness of treatment but as an adjunct to assist the physician in making the determination.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992255: Ckhemo, Model Ckhemo Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992255
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026