510(k) · Cleared
ClearedPediarity™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hinlab, Inc. · DQA Oximeter
Cleared on Dec 21, 2023 as substantially equivalent to K201770 (Masimo Corporation, 2020) after a 209-day review. Its family tree reaches back 24 generations to 1997. 2 of the 97 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 21, 2023
- Review
- 209 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 24 generations to K962603 (1997). 96 ancestors in all, the oldest K853990 (1985). No later device cites it as a predicate yet. 2 of the 97 devices in this family, counting this one, have a Class I recall.
- Root · 24 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 20 generations between
- 3 generations backK183697 Masimo Rad-97 and AccessoriesMasimo Corporation · 2019
- 2 generations backK193242 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7…Masimo Corporation · 2020
- 1 generation backK201770 Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G…Masimo Corporation · 2020 · Recalled
- This deviceK231531 Pediarity™Hinlab, Inc. · 2023
Show all 24 generations
- Root · 24 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 23 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 22 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 21 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 20 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 19 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 18 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 17 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 16 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 15 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 14 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 13 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 12 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 11 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 10 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 9 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 8 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 7 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 6 generations backK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- 5 generations backK170168 Masimo Rad-97 and AccessoriesMasimo Corporation · 2017
- 4 generations backK180046 Masimo Rad-97 and AccessoriesMasimo Corporation · 2018 · Recalled
- 3 generations backK183697 Masimo Rad-97 and AccessoriesMasimo Corporation · 2019
- 2 generations backK193242 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7…Masimo Corporation · 2020
- 1 generation backK201770 Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G…Masimo Corporation · 2020 · Recalled
- This deviceK231531 Pediarity™Hinlab, Inc. · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −23 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −22 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −21 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −20 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −19 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −18 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −17 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −16 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −15 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −14 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −13 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −12 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −11 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −10 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −9 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −8 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| −7 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| −6 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| −5 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | — |
| −4 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 1 |
| −3 | K183697 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019 | — |
| −2 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse… | Masimo Corporation | 2020 | — |
| −1 | K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable… | Masimo Corporation | 2020 | 2 |
| 0 (this device) | K231531 | Pediarity™ | Hinlab, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 1 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2017 | 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.
2 devices in this family have 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 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 |
|---|---|---|---|
| * | K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorSummary page 5…Panel: Anesthesiology 3. PREDICATE DEVICE Primary Predicate Device: Masimo Rad-G Pulse Oximeter and Accessories 510(k) number: K201770 4. REFERENCE DEVICES Device Name WesperO2 Beddr 200 System Current Health System 510(K) number… | 2020 |
| † | K213515 | WesperO2 | 2022 |
| † | K190399 | Beddr 200 System | 2019 |
| † | K231506 | Current Health System | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 26 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 22 of the 96 ancestors have a recall of any class; 2 have a Class I recall.
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 Pediarityᵀᴹ system is intended for use in the home setting for spot-checking and/or continuous recording of pulse rate (PR) and functional oxygen saturation of arterial hemoglobin (SpO2) of well-perfused infants and children in non-motion conditions.
The Pediarityᵀᴹ system is not a monitoring device and does not provide physiological alarms during use.
Measurements are sent to a web server for remote review by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231531: Pediarity™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231531
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