510(k) · Cleared
ClearedNxStage Connected Health System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · FKP System, Dialysate Delivery, Single Patient
Cleared on Sep 26, 2018 as substantially equivalent to K131739 (Nxstage Medical, Inc., 2013) after a 62-day review. Its family tree reaches back 11 generations to 1987.
- Decided
- Sep 26, 2018
- Review
- 62 days
- Class
- Class II
- Product code
- FKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K864318 (1987). 36 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations between
- 3 generations backK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- 2 generations backK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- 1 generation backK131739 Nxstage Connected Health SystemNxstage Medical, Inc. · 2013
- This deviceK181991 NxStage Connected Health SystemNxstage Medical, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 10 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 9 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 8 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 7 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 6 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 5 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 4 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 3 generations backK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- 2 generations backK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- 1 generation backK131739 Nxstage Connected Health SystemNxstage Medical, Inc. · 2013
- This deviceK181991 NxStage Connected Health SystemNxstage Medical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −10 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −9 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −8 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −7 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −6 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −5 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −4 | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| −3 | K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS) | Bl Healthcare, Inc. | 2006 | — |
| −2 | K093379 | TCX-I-DV Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| −1 | K131739 | Nxstage Connected Health System | Nxstage Medical, Inc. | 2013 | — |
| 0 (this device) | K181991 | NxStage Connected Health System | Nxstage Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 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? (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 |
|---|---|---|---|
| * | K131739 | Nxstage Connected Health SystemSummary page 5…al (GRDB) C. Predicate Devices: The predicate device is the cleared and currently marketed Connected Health System, K131739. D. Substantial Equivalence: The NxStage Connected Health device is substantially equivalent in design, function, and ope… | 2013 |
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.
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 36 ancestors have a recall of any class.
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. 2018, this device’s year, is highlighted.
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 NxStage Connected Health System is for use by chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may…
Read the full statement (189 words)
The NxStage Connected Health System is for use by chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may include the physician or licensed healthcare practitioner, other clinicians, or a disease management center.
The purpose of the system is to collect, accumulate, store and transmit medical information such as flowsheet data, vital signs, blood pressure, weight and dialysis data from the patient and transmit these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging.
The device is not intended to provide time sensitive data or alarms and does not control the System One Cycler. This system may not be used as a substitute for direct medical intervention or emergency care.
Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181991: NxStage Connected Health System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181991
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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