510(k) · Cleared
ClearedPYTON
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arm Medical Devices, Inc. · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Feb 26, 2010 as substantially equivalent to K902114 (Diemolding Corp., 1990) and 4 other predicates after a 175-day review. Its family tree reaches back 2 generations to 1991. 8 of the 33 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it.
- Decided
- Feb 26, 2010
- Review
- 175 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K912723 (1991). 5 ancestors in all, the oldest K791045 (1979). 27 later devices descend from it, 5 citing it directly. 8 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK912723 Posey CufflatorPosey Co. · 1991
- 1 generation backK081805 CuffalertSunmed · 2008
- This deviceK092733 PYTONArm Medical Devices, Inc. · 2010
- Descendant · cites it directly · 14 of its ownK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK131774 Hamilton-G5Hamilton Medical AG · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · cites it directly · 5 of its ownK150893 IntelliCuffHamilton Medical AG · 2016 · Recalled
- Descendant · 3 generations on · 4 of its ownK123637 Hamilton-C3Hamilton Medical AG · 2012
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 27 · See all- K103803Hamilton-G5Hamilton Medical AG · 2011 · cites it directly14descendants
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 2 generations on10descendants
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations on8descendants
- K150893IntelliCuffHamilton Medical AG · 2016 · cites it directly5descendants
- K123637Hamilton-C3Hamilton Medical AG · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912723 | Posey Cufflator | Posey Co. | 1991 | — |
| −1 | K081805 | Cuffalert | Sunmed | 2008 | — |
| 0 (this device) | K092733 | PYTON | Arm Medical Devices, Inc. | 2010 | — |
| +1 | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | Class I |
| +2 | K131774 | Hamilton-G5 | Hamilton Medical AG | 2013 | Class I |
| +2 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
| +1 | K150893 | IntelliCuff | Hamilton Medical AG | 2016 | 2 |
| +3 | K123637 | Hamilton-C3 | Hamilton Medical AG | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 1 |
| 2012 | 2 | 1 |
| 2013 | 3 | 2 |
| 2015 | 1 | 0 |
| 2016 | 3 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2020 | 3 | 1 |
| 2021 | 2 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
8 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 BSK device
- #1 K261499 TrachFlushscore 13.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K902114 | Cuff-Mate 2 Endotracheal Cuff Inflator & MonitorSummary page 1…BSK 7. Predicate Devices: 7.1. Cuff Mate 2 Endlotracheal Cuff Inflator and Monitor, 7.1.1.Manufacturer: Diemolding Corporation 7.1.2.FDA 510k number: K902114 7.1.3.Classification Product Code: BSK 7.2. Posey Cufflator 7.2.1.Manufacturer: Posey Co. 7.2.2.FDA 51… | 1990 |
| * | K912723 | Posey CufflatorSummary page 1….2.FDA 510k number: K902114 7.1.3.Classification Product Code: BSK 7.2. Posey Cufflator 7.2.1.Manufacturer: Posey Co. 7.2.2.FDA 510k number: K(912723 7.2.3.Classification Product Code: BSK 7.3. Rusch Endotest Cuff Pressure Monitor 7.3.1.Manufacturer: Rusch Int… | 1991 |
| * | K951046 | Rusch Endotest Cuff Pressure MonitorSummary page 1…912723 7.2.3.Classification Product Code: BSK 7.3. Rusch Endotest Cuff Pressure Monitor 7.3.1.Manufacturer: Rusch Intl. 7.3.2.FDA 510k number: K951046 7.3.3.Classification Product Code: BSK 7.4. PressureEasy Cuff Pressure Controller 7.4.1.Manufacturer: Smiths H… | 1995 |
| Kept off the family tree | K083327 | FDA’s K083327 is Syngocirculation Dynamicpet, Version 1.0 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| * | K791045 | Model GV-10 Lanz Pressure-ValveSummary page 4…Posey K791045-GV-10 Lanz 1(951046- Pressure Valve… | 1979 |
| * | K081805 | CuffalertSummary page 1…7.S.2.FDA 510k number: K(791045 7.5.3.Classlfication Product Code: BTR 7.6. CuffAlert 7.6.1.Manufacturer: SunMed 7.6.2.FDA 510k number K(081805 7.6.3.Classification Product Code: BSK Summary S&E… | 2008 |
What descends from it? (27)
See all 275 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 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.
- K103803Hamilton-G5Hamilton Medical AG · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 17.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K103803 (Hamilton Medical AG, 2011) has gone furthest, with 14 descendants of its own.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · BSK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSK
376in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSK
1in 2017
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSK
46in 2025
MAUDE reports naming product code BSK, 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 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 3 | 171 | 0 | 15 |
| 2012 | 2 | — | 0 | 62 |
| 2013 | 1 | — | 1 (1) | 16 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 4 | 376 | 0 | 1 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 51 |
| 2024 | 0 | — | 0 | 133 |
| 2025 | 2 | — | 0 | 46 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
To measure, and regulate intra-cuff pressures of endotracheal supraglottic airways or tracheostomy tubes.
The PYTON is intended for use on patients who are intubated.
The PYTON is to be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics where a patient may be intubated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092733 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092733: PYTON.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092733
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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