510(k) · Cleared
Recalled · 2009Smartmonitor 2, Model 4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Georgia, Inc. · FLS Monitor, Apnea, Facility Use
Cleared on Jan 11, 2002 as substantially equivalent to K892006 (Healthdyne, Inc., 1989) after a 232-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 11, 2002
- Review
- 232 days
- Class
- Class II
- Product code
- FLS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K892006 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK892006 Healthdyne's Apnea/Heart Monitor, Model 900SHealthdyne, Inc. · 1989
- This deviceK011597 Smartmonitor 2, Model 4000Respironics Georgia, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK032403 Smartmonitor 2 Professional Series (PS)Respironics, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK061256 Smartmonitor 2PSRespironics, Inc. · 2006 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892006 | Healthdyne's Apnea/Heart Monitor, Model 900S | Healthdyne, Inc. | 1989 | — |
| 0 (this device) | K011597 | Smartmonitor 2, Model 4000 | Respironics Georgia, Inc. | 2002 | — |
| +1 | K032403 | Smartmonitor 2 Professional Series (PS) | Respironics, Inc. | 2003 | 1 |
| +2 | K061256 | Smartmonitor 2PS | Respironics, Inc. | 2006 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 FLS? 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 |
|---|---|---|---|
| * | K892006 | Healthdyne's Apnea/Heart Monitor, Model 900SSummary page 1…ager SmartMonitor 2 / Synergy-E 4000 Series Apnea Monitor, 21 CFR 868.2377 Class Il (Special Controls) Healthdyne Technologies SmartMonitor. Originally cleared under K892006 (5/23/89). The SmartMonitor 2 is a monitoring device designed to monitor respiration and heart rate. Upon detection of abnormal… | 1989 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032403 | Smartmonitor 2 Professional Series (PS) | 2003 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2009 | Not classified | Z-1411-2009 | Process design | Audible alarm failure. |
| Oct 15, 2007 | Not classified | Z-1093-2008 | 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?
How does its category compare?
All FLS devicesFLS Monitor, Apnea, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLS
FDA has decided no FLS device since 2007.
Median 510(k) review, days · FLS
Too few FLS 510(k)s in any year since 2007 to give a median.
Recalls per year · FLS
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLS
1in 2019
MAUDE reports naming product code FLS, 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 | — | 1 | 5 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 1 | 6 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 21 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 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?
The SmartMonitor® 2 Infant Apnea Monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011597: Smartmonitor 2, Model 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011597
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026