510(k) · Cleared
ClearedMasimo Stork
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · DQA Oximeter
Cleared on Dec 15, 2023 as substantially equivalent to K203208 (Taiwan Aulisa Medical Devices Technologies, Inc., 2022) after a 368-day review. Its family tree reaches back 14 generations to 1997.
- Decided
- Dec 15, 2023
- Review
- 368 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K962603 (1997). 81 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 deviceK223721 Masimo StorkMasimo Corporation · 2023
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 deviceK223721 Masimo StorkMasimo Corporation · 2023
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) | 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 |
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? (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 |
|---|---|---|---|
| * | K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemSummary page 5…ode: FLL Establishment Registration 3011353843 Number: Reason for Premarket New Device Notification: Predicate Device: K203208 – Guardian Angel Rx GA2000 Series Digital Vital Signs Monitoring System Reference Device:… | 2022 |
| † | K191059 | Masimo Rad-97 and Accessories | 2019 |
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 26 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 81 ancestors have a recall of any class.
- 2 other devices also cite its predicate K203208.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is intended to be used in home environments.
The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants and neonates during no-motion, motion, and low perfusion conditions.
The Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223721: Masimo Stork.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223721
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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