510(k) · Cleared
ClearedAulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Aulisa Medical Devices Technologies, Inc. · DQA Oximeter
Cleared on Feb 25, 2025 as substantially equivalent to K162580 (Taiwan Aulisa Medical Devices Technologies, Inc., 2017) and 1 other predicate after a 438-day review. Its family tree reaches back 14 generations to 1997.
- Decided
- Feb 25, 2025
- Review
- 438 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K962603 (1997). 84 ancestors in all, the oldest K872291 (1987). No later device cites it as a predicate yet.
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 10 generations between
- 3 generations backK150361 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 2 generations backK183067 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019
- 1 generation backK203208 Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2022
- This deviceK233963 Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc. · 2025
Show all 14 generations
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 13 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 12 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 11 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 10 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 9 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 8 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 7 generations backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- 6 generations backK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- 5 generations backK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- 4 generations backK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 3 generations backK150361 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 2 generations backK183067 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019
- 1 generation backK203208 Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2022
- This deviceK233963 Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −13 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −12 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −11 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −10 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −9 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −8 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −7 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| −6 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| −5 | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
| −4 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| −3 | K150361 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| −2 | K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019 | — |
| −1 | K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2022 | — |
| 0 (this device) | K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring SystemSummary page 5…Class 870.2700 DQA Oximeter Class II 5.4 Predicate Device Primary Predicate K162580, Guardian Angel Rx GA1000 Series Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc.… | 2017 |
| * | K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemSummary page 5…2580, Guardian Angel Rx GA1000 Series Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc. Secondary Predicate K203208, Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc.… | 2022 |
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?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 84 ancestors have a recall of any class.
- 1 other device also cites its predicate K162580.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 Aulisa Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of adult and pediatric patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233963 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233963: Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233963
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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