510(k) · Cleared
ClearedGuardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
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 Jun 12, 2022 as substantially equivalent to K183067 (Taiwan Aulisa Medical Devices Technologies, Inc., 2019) and 2 other predicates after a 590-day review. Its family tree reaches back 13 generations to 1997. 3 later devices descend from it.
- Decided
- Jun 12, 2022
- Review
- 590 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K962603 (1997). 80 ancestors in all, the oldest K872291 (1987). 3 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations between
- 3 generations backK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 2 generations backK150361 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 1 generation backK183067 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019
- This deviceK203208 Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK233963 Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233956 Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK223721 Masimo StorkMasimo Corporation · 2023
Show all 13 generations
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 9 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 8 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 7 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 6 generations backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- 5 generations backK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- 4 generations backK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- 3 generations backK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 2 generations backK150361 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 1 generation backK183067 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019
- This deviceK203208 Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc. · 2025 · cites it directly0descendants
- K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc. · 2025 · cites it directly0descendants
- K223721Masimo StorkMasimo Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −12 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −11 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −10 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −9 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −8 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −7 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −6 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| −5 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| −4 | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
| −3 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| −2 | K150361 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| −1 | K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019 | — |
| 0 (this device) | K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2022 | — |
| +1 | K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025 | — |
| +1 | K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025 | — |
| +1 | K223721 | Masimo Stork | Masimo Corporation | 2023 | — |
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 | 3 | 0 |
| 2005 | 2 | 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 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemSummary page 5…lass II Signal Transmitter and Receiver 5.4 Predicate Device(s) Primary predicate K183067, Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc… | 2019 |
| * | K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemSummary page 6…e 2 of 11 Section 5 510(k) Summary Secondary predicate K191207, Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, In… | 2019 |
| * | K181013 | Fever ScoutSummary page 6… K191207, Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc. K181013, Fever Scout™ Continuous Monitoring Thermometer, VivaLnk Inc. 5.5 Device Description The subject device is a… | 2018 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 10 of the 80 ancestors have a recall of any class.
- Of its descendants, K233963 (Taiwan Aulisa Medical Devices Technologies, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
GA2000 The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2000) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring…
Read the full statement (411 words)
GA2000
The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2000) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions.
GA2001
The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2001) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions.
GA2002
The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2002) is indicated for use in measuring, recording, and displaying body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.
GA2100
The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2100) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions.
The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.
GA2101
The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2101) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.
The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions.
The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203208 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203208: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203208
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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