510(k) · Cleared
ClearedMightySat -OTC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · OLK Pulse Oximeter For Over-The-Counter Use
Cleared on Jan 31, 2024 as substantially equivalent to K181956 (Masimo Corporation, 2019) after a 762-day review. Its family tree reaches back 20 generations to 1997. 1 of the 113 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jan 31, 2024
- Review
- 762 days
- Class
- Class II
- Product code
- OLK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K962603 (1997). 111 ancestors in all, the oldest K853990 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 113 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 16 generations between
- 3 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 2 generations backK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- 1 generation backK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- This deviceK214115 MightySat -OTCMasimo Corporation · 2024
- Descendant · cites it directly · 0 of its ownK211498 Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc. · 2024
Show all 20 generations
- Root · 20 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 19 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 18 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 17 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 16 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 15 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 14 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 13 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 12 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 11 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 10 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 9 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 8 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 7 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 6 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 5 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 4 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 3 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 2 generations backK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- 1 generation backK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- This deviceK214115 MightySat -OTCMasimo Corporation · 2024
Class I recalls in this family
- K970209 Capnocheck Plus8 generations back · 1997
Most influential descendants
Showing 1 of 1 · See all- K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −19 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −18 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −17 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −16 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −15 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −14 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −13 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −12 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −11 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −10 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −9 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −8 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −7 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −6 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −5 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −4 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| −3 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| −2 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
| −1 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | — |
| 0 (this device) | K214115 | MightySat -OTC | Masimo Corporation | 2024 | — |
| +1 | K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 1 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 1 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
1 device in this family has a Class I recall. 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 OLK device
- #1 K211498 Nonin OTC Pulse Oximeter Model 3250score 14.3 · 21 generations · no Class I recall
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 |
|---|---|---|---|
| * | K181956 | Masimo MightySat Rx Fingertip Pulse OximeterSummary page 4…3011353843 Number: Reason for Premarket Over-the-counter use Notification: Primary Predicate: K181956 – Masimo MightySat Fingertip Pulse Oximeter Performance Standards No performance standards for the above device have b… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250 | 2024 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 8 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 18 of the 111 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K211498 (Nonin Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K181956.
How does its category compare?
All OLK devicesOLK Pulse Oximeter For Over-The-Counter Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OLK
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OLK
Too few OLK 510(k)s in any year since 2007 to give a median.
Recalls per year · OLK
No recall names OLK since 2007.
Adverse event reports per year · OLK
1in 2011
MAUDE reports naming product code OLK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Masimo MightySat-OTC is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Masimo MightySat-OTC is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions.
The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease and treatment decisions using the device should only be under the advice of a healthcare provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214115: MightySat -OTC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214115
Report an extraction error
Are you the manufacturer?
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