510(k) · Cleared
ClearedSatmaster, Computerized Pulse Oximetry Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emg Scientific · DQA Oximeter
Cleared on Dec 4, 1996 as substantially equivalent to K863784 (Nellcor, Inc., 1986) and 1 other predicate after a 567-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Dec 4, 1996
- Review
- 567 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K863784 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK863784 Nellcor N-200 (Pulse Oximeter)Nellcor, Inc. · 1986
- This deviceK952315 Satmaster, Computerized Pulse Oximetry SoftwareEmg Scientific · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863784 | Nellcor N-200 (Pulse Oximeter) | Nellcor, Inc. | 1986 | — |
| 0 (this device) | K952315 | Satmaster, Computerized Pulse Oximetry Software | Emg Scientific | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 |
|---|---|---|---|
| * | K863784 | Nellcor N-200 (Pulse Oximeter)Summary page 2…vs. time, histograms, and certain statistics. Here is a list of the Pulse Oximeters that SatMasicr has been designed to work with: —————— Nellcor N-200 Puise Oximeter K863784 21 November 1986 Nelicor | Symphony N-3000 Pulse Oximeter K942347 12 May 1995 Ohmeda Biox 3700 Pulse Oximeter K850494 28 March… | 1986 |
| * | K901399 | Powerbase II (PB2)Summary page 2…s the N-250 Pulse Oximcter. The FDA 510(k) clearances for these two Nellcor products are: Nellcor N-200 Pulse Oximetcr K863784 (21 November 1986) Nellcor N-50 Powerbase K901399 (12 June 1990) The features of thesc two devices that arc rclcvant to this discussion are as follows. The Nelicor N-200 Pulse Ox… | 1990 |
| † | K942347 | Nellcor Symphony Pulse Oximeter Model N-3000 | 1995 |
| † | K850494 | Ohmeda Biox 3700 Pulse Oximeter | 1985 |
| † | K872772 | Ohmeda Biox 3740 Pulse Oximeter | 1987 |
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?
- None of the 2 ancestors has a recall.
- 13 other devices also cite its predicate K863784.
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?
SatMaster is intended for use as an adjunct to traditional Pulse Oximetry, in which the caregiver observes instantaneous Pulse Oximetry values as displayed on a Pulse Oximeter’s face. SatMaster produces graphs and statistics describing a patient’s Pulse Oximetry data trends over relatively long periods of time, including those times when the caregiver is not directly observing the Pulse Oximeter’s display. In a hospital setting, SatMaster would be used…
Read the full statement (119 words)
SatMaster is intended for use as an adjunct to traditional Pulse Oximetry, in which the caregiver observes instantaneous Pulse Oximetry values as displayed on a Pulse Oximeter’s face. SatMaster produces graphs and statistics describing a patient’s Pulse Oximetry data trends over relatively long periods of time, including those times when the caregiver is not directly observing the Pulse Oximeter’s display.
In a hospital setting, SatMaster would be used in association with ICU’s, Operating and Recovery Rooms, Pulmonary Function Labs, Sleep Labs, and research.
In home-care settings, SatMaster would be used for sleep studies and home-oxygen evaluations.
It is expected that the Pulse Oximeter itself will be operated by competent personnel in accordance with the Pulse Oximeter manufacturer’s FDA-approved instructions.
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/K952315 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952315: Satmaster, Computerized Pulse Oximetry Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952315
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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