510(k) · Cleared
ClearedAnura Mobile Core SDK (M1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuralogix Corporation · QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Cleared on Jun 11, 2026 as substantially equivalent to K223622 (Faceheart Corp., 2023) and 1 other predicate after a 203-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Jun 11, 2026
- Review
- 203 days
- Class
- Class II
- Product code
- QME
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913396 (1992). 54 ancestors in all, the oldest K830295 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations between
- 3 generations backK151940 Thora-3Di, Model T-01Pneumacare Limited · 2016
- 2 generations backK242001 Philips VSC-MEDlibPhilips Medical Systems Nederland B.V. · 2025
- 1 generation backK243966 FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp. · 2025
- This deviceK253650 Anura Mobile Core SDK (M1)Nuralogix Corporation · 2026
Show all 10 generations
- Root · 10 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 9 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 8 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 7 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 6 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 5 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 4 generations backK090273 Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai…Kai Sensors, Inc. · 2009
- 3 generations backK151940 Thora-3Di, Model T-01Pneumacare Limited · 2016
- 2 generations backK242001 Philips VSC-MEDlibPhilips Medical Systems Nederland B.V. · 2025
- 1 generation backK243966 FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp. · 2025
- This deviceK253650 Anura Mobile Core SDK (M1)Nuralogix Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −9 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −8 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −7 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −6 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −5 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −4 | K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot… | Kai Sensors, Inc. | 2009 | — |
| −3 | K151940 | Thora-3Di, Model T-01 | Pneumacare Limited | 2016 | — |
| −2 | K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | 2025 | — |
| −1 | K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | 2025 | — |
| 0 (this device) | K253650 | Anura Mobile Core SDK (M1) | Nuralogix Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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.
Planning a device in QME? 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 QME device
- #1 K211906 Vital Signsscore 28.7 · 1 generation · 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 |
|---|---|---|---|
| * | K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK)Summary page 5…FH vitals SDK-RR Manufacturer FaceHeart Corporation FaceHeart Corporation 510(k) Number K223622 K243966 Date Cleared September 1, 2023 April 9, 20… | 2023 |
| * | K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Summary page 5…Manufacturer FaceHeart Corporation FaceHeart Corporation 510(k) Number K223622 K243966 Date Cleared September 1, 2023 April 9, 2025 Device Description Anura Mobile Core SDK… | 2025 |
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 34 years and passes through 11 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 54 ancestors have a recall of any class.
How does its category compare?
All QME devicesQME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QME
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QME
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QME
No recall names QME since 2007.
Adverse event reports per year · QME
No MAUDE report names QME since 2007.
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 | 0 |
| 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 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 266 | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 4 | 190 | 0 | — |
What is it indicated for?
Anura Mobile Core SDK (AMC-SDK) is designed to use Transdermal Optical Imaging (TOI) for non-invasive spot (discrete) measurement of pulse rate and breathing rate (chest wall movements) when the subject is relaxed, still, and seated upright. AMC-SDK can be used for general healthcare in adults 18 years of age or older, but is not designed to treat or diagnose patients. The measurement results should complement, but not replace, the user's professional…
Read the full statement (126 words)
Anura Mobile Core SDK (AMC-SDK) is designed to use Transdermal Optical Imaging (TOI) for non-invasive
spot (discrete) measurement of pulse rate and breathing rate (chest wall movements) when the subject is
relaxed, still, and seated upright.
AMC-SDK can be used for general healthcare in adults 18 years of age or older, but is not designed to treat
or diagnose patients. The measurement results should complement, but not replace, the user's
professional medical care and/or medication. If abnormalities are detected during the measurement with the
SDK, users are advised to consult a medical professional.
AMC-SDK is not intended to be the sole method of checking the physical health of a subject.
AMC-SDK is not desiqned to function as an apnea monitor or to detect cessation of breathinq_
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253650: Anura Mobile Core SDK (M1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253650
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026