510(k) · Cleared
ClearedCyberren
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybernius Medical, Ltd. · KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
Cleared on Jul 24, 1997 after a 128-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Jul 24, 1997
- Review
- 128 days
- Class
- Class II
- Product code
- KPF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK970989 CyberrenCybernius Medical, Ltd. · 1997
- Descendant · cites it directly · 5 of its ownK083158 Exalis, Software Version 1.15Gambro, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK131739 Nxstage Connected Health SystemNxstage Medical, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK101078 BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · 4 generations on · 0 of its ownK181991 NxStage Connected Health SystemNxstage Medical, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K083158Exalis, Software Version 1.15Gambro, Inc. · 2009 · cites it directly5descendants
- K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010 · 2 generations on4descendants
- K131739Nxstage Connected Health SystemNxstage Medical, Inc. · 2013 · 3 generations on1descendant
- K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010 · 3 generations on1descendant
- K181991NxStage Connected Health SystemNxstage Medical, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970989 | Cyberren | Cybernius Medical, Ltd. | 1997 | — |
| +1 | K083158 | Exalis, Software Version 1.15 | Gambro, Inc. | 2009 | — |
| +2 | K093379 | TCX-I-DV Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +3 | K131739 | Nxstage Connected Health System | Nxstage Medical, Inc. | 2013 | — |
| +3 | K101078 | BL Healthcare Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +4 | K181991 | NxStage Connected Health System | Nxstage Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
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 KPF? 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083158 | Exalis, Software Version 1.15 | 2009 | 5 |
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?
- Of its descendants, K083158 (Gambro, Inc., 2009) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KPF devicesKPF System, Dialysate Delivery, Semi-Automatic, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPF
FDA has decided no KPF device since 2007.
Median 510(k) review, days · KPF
Too few KPF 510(k)s in any year since 2007 to give a median.
Recalls per year · KPF
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPF
1in 2018
MAUDE reports naming product code KPF, 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 | — | 2 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
cyberREN is a clinical data management system, designed specifically for nephrology, to replace the paper medical chart. Full chart replacement, i.e. a conversion from a paper medical record to an electronic medical record is at the option of the client. The cyberREN electronic chart essentially provides the functions of a data repository and data query / reporting system. The cyberREN electronic chart has the following properties: • The chart is access…
Read the full statement (1,365 words)
cyberREN is a clinical data management system, designed specifically for nephrology, to replace the paper medical chart. Full chart replacement, i.e. a conversion from a paper medical record to an electronic medical record is at the option of the client. The cyberREN electronic chart essentially provides the functions of a data repository and data query / reporting system.
The cyberREN electronic chart has the following properties:
• The chart is access restricted, and requires the entry of an account name and password, which is unique and private to each user of the system.
• Most entries into the chart are made manually by caregivers, and are automatically stamped with the time and date of entry, as well as with the author’s electronic signature.
• Elements of the chart cannot be erased. Additionally, an electronic audit trail registers all changes to the chart in duplicate.
• The cyberREN system is intended for multiuser operations - several users can access the system simultaneously. It is a multidisciplinary system, providing services for physicians, nursing staff and other disciplines supplying services in the treatment of kidney disease.
A cyberREN workplace consists of a standard Windows 95 based computer, which hosts the cyberREN user interface program. The workplaces are positioned in the caregivers offices, and at strategic locations in the ward close to where the medical staff are delivering heath care services.
The cyberREN system is used to:
save clinical information - the majority of clinical data maintained by the cyberREN data repository is entered manually by caregivers, while other data is received from networked systems, specifically laboratory results. Data describing the ongoing dialysis process is received directly from the Fresenius 2008H dialysis machine and entered into the cyberREN medical record.
calculate values - cyberREN calculates a limited number of values, based on laboratory data received and data entered manually. Calculated values are summarized below:
• weight gain between dialysis sessions, calculated with every new dialysis session charted
• protein catabolic rate, percent urea reduction, and the KT/V dialysis efficacy index, typically calculated as a measure of observed treatment efficiency once per month based on patient weights and pre and post dialysis urea laboratory results.
• nutrition parameters, e.g. desired calorific intake being the simple sum of recommendations entered by the caregiver, i.e. to account for normal metabolic consumption, activity, stress and desired weight gain. A calculation for desired protein intake is also carried out, based on the simple product of an ideal body weight and upper and lower limits of a protein intake range, both parameters entered by the caregiver. These values are displayed on the screen, together with the entered parameters upon which the calculation is based.
display clinical information - both data entered manually or received from other computer systems or dialysis machines are displayed at the cyberREN workplaces throughout the facility. Approximately 300 computer displays are provided to show various elements of the medical chart. Special displays combine information from several sections of the chart on a single display.
report clinical information - data entered manually or received from other computer systems may be compiled into a printed report, which contains information from various parts of the electronic chart. Approximately 70 predefined reports are available for printout.
General Charting
patient demographics - cyberREN is used to register patients’ personal information, contacts, insurance carriers, social conditions, renal diagnoses, treatment institute, treatment modality, etc.
patient problems - cyberREN allows the medical staff to maintain a problem list for each patient. Other elements of the chart, e.g. medications, may be linked to one of the problems in the Problem List.
orders/ order processing - cyberREN registers orders initiated by the physician and presents these on further displays, where they are important for the caregiver. cyberREN also requires the physician to verify verbal or telephone orders, and allows caregivers to document that the orders have been completed.
medications - cyberREN allows physicians to order medications by selecting the medication by name, and defining its dosage, route to be administered and frequency, among other parameters.
progress notes / patient encounters - physicians and other caregivers may enter free text notes which describe the results of an encounter with the patient. The user may assign a CPT code to the patient encounter for billing purposes.
consultations - cyberREN allows the caregiver to keep track of all consultations external to the treating facility. The nature and purpose of the consultation as well as the consulting physician and the consultation’s results may be entered into and subsequently reported by the cyberREN system
laboratory results reporting - cyberREN receives laboratory results for individual patients and displays these on lab result screens or on reports. Results may enter the cyberREN system through manual data entry or through automated electronic data import from a dedicated laboratory computer system or hospital system. Standard communication protocols (HL7), ASCII file import as well as custom communication protocols are employed in the import process
billable services - cyberREN registers all billable services in a journal for subsequent reporting and submission to a computer system, whose function is billing claim preparation and reconciliation.
Nutrition - the nutritionist and dietary staff may use cyberREN to document their goals and objectives for the patient as well as the patients nutritional status i.e. current diet etc. cyberREN may also be used to document nutritionists recommendations for fluid intake and intake of other important elements such as protein, potassium etc..
Hemodialysis
hemodialysis treatment orders - cyberREN registers orders for the hemodialysis prescription created by the physician. Caregivers may display or print the order for an individual patient when setting up the hemodialysis machine for a treatment on a given day.
hemodialysis session charting - cyberREN is used by the medical staff administering the hemodialysis treatment to register the patients condition that the start and end of treatment as well as during the treatment. All medical events occurring during treatment, including medications administered, may be entered by medical staff for later query and reporting. cyberREN may automatically obtain current treatment parameters directly from the dialysis machine for entry into the hemodialysis treatment log. Entries may be checked or made manually by medical staff as well. A maximum of 30 dialysis machines may be monitored by a Intel Pentium based cyberREN system.
hemodialysis access charting - cyberREN may be used to document the hemodialysis access i.e. medical procedures creating or correcting the access, as well as to document problems occurring with the access.
patient/ward hemodialysis schedule - users may enter and view the hemodialysis schedule i.e. the use of hemodialysis machines by the patient population, to assist in scheduling activities.
Peritoneal Dialysis
peritoneal dialysis orders - cyberREN registers orders for the peritoneal dialysis prescription created by the physician. Caregivers may display or print the order for an individual patient when administering the treatment or when advising the patient of therapy changes.
peritoneal dialysis session charting - cyberREN is used by the medical staff, administering the peritoneal dialysis treatment within the facility, to register the patients condition that the start and end of treatment as well as during the treatment. All medical events occurring during treatment may be entered by medical staff for later query and reporting.
peritonitis charting - episodes of peritonitis, which the patient has experienced may be entered into the cyberREN system for later query and reporting.
peritoneal access charting - cyberREN may be used to document the peritoneal dialysis access i.e. medical procedures creating or correcting the access, as well as to document problems occurring with the access.
Transplant
transplant status - the caregivers may use cyberREN to document the patient’s status on the Transplant List (list of transplant candidates).
transplant workup - caregivers may use cyberREN to register and follow up on the activities required for preparing the patient for a possible kidney transplant.
cyberREN does not:
• logically alter information entered by medical staff, or imported directly from other systems,
• make any recommendations for treatment or treatment parameters,
• influence the operation of the Fresenius 2008H dialysis machine in any way. Communications with the 2008H device is uni-directional, with cyberREN receiving data at a predefined schedule determined by the dialysis machine.
• provide a diagnosis or provide a selection of possible diagnoses.
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/K970989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970989: Cyberren.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970989
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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