510(k) · Cleared
ClearedThora-3Di, Model T-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pneumacare Limited · BZQ Monitor, Breathing Frequency
Cleared on Mar 10, 2016 as substantially equivalent to K090273 (Kai Sensors, Inc., 2009) after a 240-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- Mar 10, 2016
- Review
- 240 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913396 (1992). 48 ancestors in all, the oldest K830295 (1983). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 5 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 4 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 3 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 2 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 1 generation backK090273 Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai…Kai Sensors, Inc. · 2009
- This deviceK151940 Thora-3Di, Model T-01Pneumacare Limited · 2016
- Descendant · cites it directly · 2 of its ownK242001 Philips VSC-MEDlibPhilips Medical Systems Nederland B.V. · 2025
- Descendant · 2 generations on · 1 of its ownK243966 FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp. · 2025
- Descendant · 3 generations on · 0 of its ownK253650 Anura Mobile Core SDK (M1)Nuralogix Corporation · 2026
Most influential descendants
Showing 3 of 3 · See all- K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V. · 2025 · cites it directly2descendants
- K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp. · 2025 · 2 generations on1descendant
- K253650Anura Mobile Core SDK (M1)Nuralogix Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −6 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −5 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −4 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −3 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −2 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −1 | K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot… | Kai Sensors, Inc. | 2009 | — |
| 0 (this device) | K151940 | Thora-3Di, Model T-01 | Pneumacare Limited | 2016 | — |
| +1 | K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | 2025 | — |
| +2 | K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | 2025 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 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 BZQ? 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 BZQ device
- #1 K251326 Respiration Rate algorithmscore 20.2 · 30 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 |
|---|---|---|---|
| * | K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Summary page 4…Frequency Monitor Device Classification: 21 CFR 868.2375, Breathing Frequency Monitor Product Code BZQ Predicate Device: K090273, Kai Spot KMS200, Kai Medical Predicate Device 21 CFR 868.2375, Breathing Frequency Monitor Classification:… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242001 | Philips VSC-MEDlib | 2025 | 2 |
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 24 years and passes through 8 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 48 ancestors have a recall of any class.
- Of its descendants, K242001 (Philips Medical Systems Nederland B.V., 2025) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K090273.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · BZQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZQ
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZQ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZQ
2in 2022
MAUDE reports naming product code BZQ, 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 | 2 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 121 | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 3 | 261 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 3 | 198 | 0 | 10 |
| 2019 | 1 | — | 0 | 13 |
| 2020 | 2 | — | 0 | 10 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 198 | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 7 | 255 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Thora-3Di is intended for a one-time measurement of respiratory rate as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.
The Thora-3Di is not intended to monitor vital signs. This device is not an apnea monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151940 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151940: Thora-3Di, Model T-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151940
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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