510(k) · Cleared
ClearedAG Guffill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospitech Respiration, Ltd. · BSK Cuff, Tracheal Tube, Inflatable
Cleared on May 3, 2013 as substantially equivalent to K912723 (Posey Co., 1991) and 3 other predicates after a 240-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- May 3, 2013
- Review
- 240 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K912723 (1991). 7 ancestors in all, the oldest K791045 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK912723 Posey CufflatorPosey Co. · 1991
- 2 generations backK081805 CuffalertSunmed · 2008
- 1 generation backK092733 PYTONArm Medical Devices, Inc. · 2010
- This deviceK122721 AG GuffillHospitech Respiration, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK242642 CuffTrekShanghai Longmann Tech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK192611 CuffixBiovo Technologies, Ltd. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912723 | Posey Cufflator | Posey Co. | 1991 | — |
| −2 | K081805 | Cuffalert | Sunmed | 2008 | — |
| −1 | K092733 | PYTON | Arm Medical Devices, Inc. | 2010 | — |
| 0 (this device) | K122721 | AG Guffill | Hospitech Respiration, Ltd. | 2013 | — |
| +1 | K242642 | CuffTrek | Shanghai Longmann Tech Co., Ltd. | 2025 | — |
| +1 | K192611 | Cuffix | Biovo Technologies, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K912723 | Posey CufflatorSummary page 2…Device Name 510k No .. Date of Clearance Posey Cufflator K912723 July 20 1991 CuffAlert K081805… | 1991 |
| * | K081805 | CuffalertSummary page 2…Posey Cufflator K912723 July 20 1991 CuffAlert K081805 Nov 14 2008 Easy Cuff K102704… | 2008 |
| * | K102704 | Easy CuffSummary page 2…CuffAlert K081805 Nov 14 2008 Easy Cuff K102704 March 10 2011 PYTON K092733… | 2011 |
| * | K092733 | PYTONSummary page 2…Easy Cuff K102704 March 10 2011 PYTON K092733 Feb 26 2010 Performance Standards AG Cuff!!l co… | 2010 |
What descends from it? (2)
2 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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K242642 (Shanghai Longmann Tech Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K912723.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Hospitech AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways).
The Hospitech AG Cuffill is 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/K122721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122721: AG Guffill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122721
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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