510(k) · Cleared
Recalled · 2002Model 509M Pulse Oximeter, Model 509M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Novametrix, Inc. · DQA Oximeter
Cleared on May 21, 2004 as substantially equivalent to K993979 (Novametrix Medical Systems, Inc., 2000) and 1 other predicate after a 259-day review. Its family tree reaches back 5 generations to 1997. It has been recalled once.
- Decided
- May 21, 2004
- Review
- 259 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962603 (1997). 8 ancestors in all, the oldest K913516 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 2 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 1 generation backK993979 MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 2000 · Recalled
- This deviceK032755 Model 509M Pulse Oximeter, Model 509MRespironics Novametrix, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −2 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −1 | K993979 | MARSPO2, Model 2001 | Novametrix Medical Systems, Inc. | 2000 | 1 |
| 0 (this device) | K032755 | Model 509M Pulse Oximeter, Model 509M | Respironics Novametrix, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 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 DQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K993979 | MARSPO2, Model 2001Summary page 1…ished accuracy specifications with the Model 2001. The predicate device is as follows: 1. Model 2001 Pulse Oximeter, Novametrix Medical Systems, Inc., K993979,K000794) e. Device Description The Model 509M Pulse Oximeter Module is designed for continuous, non-invasive… | 2000 |
| * | K000794 | Modification to MARSPO2, Model 2001Summary page 1…curacy specifications with the Model 2001. The predicate device is as follows: 1. Model 2001 Pulse Oximeter, Novametrix Medical Systems, Inc., K993979,K000794) e. Device Description The Model 509M Pulse Oximeter Module is designed for continuous, non-invasive monito… | 2000 |
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 |
|---|---|---|---|---|
| Sep 2, 2002 | Not classified | Z-1049-04 | Other | Audio alarm may fail to sound when SpO2 limits drop below the set limits |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 3 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K993979.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The Model 509M Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well. or poorly perfused in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032755: Model 509M Pulse Oximeter, Model 509M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032755
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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