510(k) · Cleared
ClearedCannula Style Thermocouples
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro-Tech, Inc. · BZG Spirometer, Diagnostic
Cleared on May 22, 1992 after a 297-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 109 later devices descend from it.
- Decided
- May 22, 1992
- Review
- 297 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
109 later devices descend from it, 3 citing it directly.
- This deviceK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- Descendant · cites it directly · 106 of its ownK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- Descendant · 2 generations on · 99 of its ownK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- Descendant · 3 generations on · 98 of its ownK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- Descendant · 4 generations on · 54 of its ownK041904 Compass F10 SystemMedcare Flaga · 2004
- Descendant · 5 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K982293Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998 · cites it directly106descendants
- K020607Sleepflo, Model 101501Biomec, Inc. · 2002 · 2 generations on99descendants
- K030379Aplab, Model 801D0030Sector Medical Corp. · 2003 · 3 generations on98descendants
- K041904Compass F10 SystemMedcare Flaga · 2004 · 4 generations on54descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 5 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| +1 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| +2 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| +3 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| +4 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| +5 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZG? 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 BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (109)
See all 1093 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K982293 (Pro-Tech Services, Inc., 1998) has gone furthest, with 106 descendants of its own.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, 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 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K913396 · printed Nov 5, 2026
Cite this page
510(k) Report. “K913396: Cannula Style Thermocouples.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K913396
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026