510(k) · Cleared
ClearedSentinel BreastScan II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
First Sense Medical, LLC · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Jan 9, 2017 as substantially equivalent to K032350 (Infrared Sciences Corp., 2004) after a 101-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jan 9, 2017
- Review
- 101 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951806 (1995). 7 ancestors in all, the oldest K812799 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK951806 Opgal Intraoperative Vascular Angiography System (Iva-2000)Opgal Optronic Industries · 1995
- 3 generations backK982327 Inframetrics Infracam-MedInframetrics, Inc. · 1998
- 2 generations backK990416 Omnicorder Bioscan SystemOmnicorder Technologies, Inc. · 1999
- 1 generation backK032350 Infrared Sciences Breastscan IR SystemInfrared Sciences Corp. · 2004
- This deviceK162767 Sentinel BreastScan II SystemFirst Sense Medical, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951806 | Opgal Intraoperative Vascular Angiography System (Iva-2000) | Opgal Optronic Industries | 1995 | — |
| −3 | K982327 | Inframetrics Infracam-Med | Inframetrics, Inc. | 1998 | — |
| −2 | K990416 | Omnicorder Bioscan System | Omnicorder Technologies, Inc. | 1999 | — |
| −1 | K032350 | Infrared Sciences Breastscan IR System | Infrared Sciences Corp. | 2004 | — |
| 0 (this device) | K162767 | Sentinel BreastScan II System | First Sense Medical, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 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 LHQ? 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 LHQ device
- #1 K253911 Derma-2score 12.0 · 3 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 |
|---|---|---|---|
| * | K032350 | Infrared Sciences Breastscan IR SystemSummary page 4…ion Name Telethermographic System (Adjunctive Use) Product Code: LHQ 21 C.F.R. 884.2980 Predicate Devices Infrared Sciences Corp., BreastScan IR (K032350) Purpose of the Special 510(k) Notice The Sentinel BreastScan II System is a modification to the Infrared Sciences Corp. Breast… | 2004 |
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 22 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K032350.
How does its category compare?
All LHQ devicesLHQ System, Telethermographic (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LHQ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LHQ
Too few LHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LHQ
No recall names LHQ since 2007.
Adverse event reports per year · LHQ
1in 2025
MAUDE reports naming product code LHQ, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Sentinel BreastScan II System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162767: Sentinel BreastScan II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162767
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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