510(k) · Cleared
Recalled · 2007Smartmonitor 2 Professional Series (PS)
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 Oct 27, 2003 as substantially equivalent to K011597 (Respironics Georgia, Inc., 2002) and 1 other predicate after an 84-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 27, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- NPF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962603 (1997). 5 ancestors in all, the oldest K892006 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 2 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 1 generation backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- This deviceK032403 Smartmonitor 2 Professional Series (PS)Respironics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK061256 Smartmonitor 2PSRespironics, Inc. · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K061256Smartmonitor 2PSRespironics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −2 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −1 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| 0 (this device) | K032403 | Smartmonitor 2 Professional Series (PS) | Respironics, Inc. | 2003 | — |
| +1 | K061256 | Smartmonitor 2PS | Respironics, Inc. | 2006 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2002 | 1 | 0 |
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 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 |
|---|---|---|---|
| * | K011597 | Smartmonitor 2, Model 4000 | 2002 |
| * | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor…Summary page 1…DQA -Oximeter Predicate Devices Respironics SmartMonitor 2 (KO11597) Masimo SET Oximeter (K990966) Reason for submission Additional or expanded indications Substantial Equivalence This premarket no… | 1999 |
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 |
|---|---|---|---|
| K061256 | Smartmonitor 2PS | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2007 | Not classified | Z-1091-2008 | 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 6 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K061256 (Respironics, Inc., 2006) has gone furthest, with 0 descendants of its own.
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 2 Professional Series Infant Apnea Monitor is intended for use in the continuous monitoring of respiration, heart rate, and SpO2 of infant patients in a hospital or home environment. The monitor detects and alarms for periods of central apnea, high or low heart rate, and high or low saturation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032403 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032403: Smartmonitor 2 Professional Series (PS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032403
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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