510(k) · Cleared
Recalled · Class II · 2017Smartmonitor 2PS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · NPF Monitor, Apnea, Home Use
Cleared on Aug 2, 2006 as substantially equivalent to K032403 (Respironics, Inc., 2003) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1991. It has been recalled 3 times.
- Decided
- Aug 2, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- NPF
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 4 generations to K910772 (1991). 15 ancestors in all, the oldest K892006 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 3 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 1 generation backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- This deviceK061256 Smartmonitor 2PSRespironics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −3 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −1 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K061256 | Smartmonitor 2PS | Respironics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 NPF? 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? (2)
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 |
|---|---|---|---|
| * | K032403 | Smartmonitor 2 Professional Series (PS)Summary page 1…ate Classification Panel Anesthesiology Product Code NPF, BZQ, and DQA Predicate Devices Respironics, Inc. SmartMonitor 2PS (K032403) CAS Medical Systems, Inc. 9303 Neonatal/Adult Vital Signs… | 2003 |
| * | K982776 | 9303 Neonatal/Adult Vital Signs MonitorSummary page 1…nc. SmartMonitor 2PS (K032403) CAS Medical Systems, Inc. 9303 Neonatal/Adult Vital Signs Monitor (K982776) Reason for submission Modified Indications for use and design ©2006 Respironics Inc. 07/… | 1998 |
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 |
|---|---|---|---|---|
| May 1, 2017 | Class II | Z-2250-2017 | Under Investigation by firm | Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "Nurse Call" feature to ensure monitor… |
| Apr 29, 2014 | Class II | Z-1789-2014 | Component design/selection | The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error… |
| Oct 15, 2007 | Not classified | Z-1086-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 3 of the 15 ancestors have a recall of any class.
How does its category compare?
All NPF devicesNPF Monitor, Apnea, Home Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NPF
FDA has decided no NPF device since 2007.
Median 510(k) review, days · NPF
Too few NPF 510(k)s in any year since 2007 to give a median.
Recalls per year · NPF
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPF
1in 2022
MAUDE reports naming product code NPF, 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 | 5 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SmartMonitor 2PS is intended for use in the continuous monitoring of respiration, heart rate and SpO₂ levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult…
Read the full statement (174 words)
The SmartMonitor 2PS is intended for use in the continuous monitoring of respiration, heart rate and SpO₂ levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
The SmartMonitor 2PSL is intended for use in the continuous monitoring of respiration, and heart rate of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, and high or low breath rate. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061256: Smartmonitor 2PS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061256
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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