510(k) · Cleared
ClearedCuffix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biovo Technologies, Ltd. · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Aug 13, 2020 as substantially equivalent to K122721 (Hospitech Respiration, Ltd., 2013) and 1 other predicate after a 328-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Aug 13, 2020
- Review
- 328 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K912723 (1991). 9 ancestors in all, the oldest K791045 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK912723 Posey CufflatorPosey Co. · 1991
- 3 generations backK081805 CuffalertSunmed · 2008
- 2 generations backK092733 PYTONArm Medical Devices, Inc. · 2010
- 1 generation backK122721 AG GuffillHospitech Respiration, Ltd. · 2013
- This deviceK192611 CuffixBiovo Technologies, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912723 | Posey Cufflator | Posey Co. | 1991 | — |
| −3 | K081805 | Cuffalert | Sunmed | 2008 | — |
| −2 | K092733 | PYTON | Arm Medical Devices, Inc. | 2010 | — |
| −1 | K122721 | AG Guffill | Hospitech Respiration, Ltd. | 2013 | — |
| 0 (this device) | K192611 | Cuffix | Biovo Technologies, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2011 | 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 BSK? 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? (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 |
|---|---|---|---|
| * | K122721 | AG GuffillSummary page 4…Review Panel: Anesthesiology 5.3 PREDICATE DEVICE Primary predicate device: • AG Cuffill, manufactured by Hospitech Respiration Ltd., cleared under K122721, product code: BSK Reference device: • PressureEasy Cuff Pressure Controller, manufactured by Smith Medical Inc., clea… | 2013 |
| * | K833327 | Respironics PR ValveSummary page 4…, cleared under K122721, product code: BSK Reference device: • PressureEasy Cuff Pressure Controller, manufactured by Smith Medical Inc., cleared under K833327, product code: BSK. Page 1 of 4 Cuffix - S… | 1983 |
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 29 years and passes through 5 companies; a new generation was cleared every 7.3 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K122721.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Cuffix is intended to measure and regulate, through passive control, the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192611: Cuffix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192611
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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