510(k) · Cleared
ClearedEasy Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joan Spiegel, MD · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Mar 10, 2011 as substantially equivalent to K912723 (Posey Co., 1991) and 1 other predicate after a 171-day review. Its family tree reaches back 2 generations to 1991. 7 later devices descend from it.
- Decided
- Mar 10, 2011
- Review
- 171 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K912723 (1991). 3 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK912723 Posey CufflatorPosey Co. · 1991
- 1 generation backK081805 CuffalertSunmed · 2008
- This deviceK102704 Easy CuffJoan Spiegel, MD · 2011
- Descendant · cites it directly · 3 of its ownK142103 Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK122721 AG GuffillHospitech Respiration, Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK242642 CuffTrekShanghai Longmann Tech Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK192611 CuffixBiovo Technologies, Ltd. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142103Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015 · cites it directly3descendants
- K122721AG GuffillHospitech Respiration, Ltd. · 2013 · cites it directly2descendants
- K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017 · 2 generations on1descendant
- K242642CuffTrekShanghai Longmann Tech Co., Ltd. · 2025 · 2 generations on0descendants
- K192611CuffixBiovo Technologies, Ltd. · 2020 · 2 generations on0descendants
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) | K102704 | Easy Cuff | Joan Spiegel, MD | 2011 | — |
| +1 | K142103 | Cuff Pilot, Sure Seal | Teleflexmedical, Inc. | 2015 | — |
| +1 | K122721 | AG Guffill | Hospitech Respiration, Ltd. | 2013 | — |
| +2 | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017 | — |
| +2 | K242642 | CuffTrek | Shanghai Longmann Tech Co., Ltd. | 2025 | — |
| +2 | K192611 | Cuffix | Biovo Technologies, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K912723 | Posey CufflatorSummary page 1…: Cuff, tracheal tube, inflatable (accessory) BSK - 868.5730 Predicate Devices: Posey Cufflator - K912723 SunMed CuffAert TM - K081805 Device Description: The Easy CuffTm is simple in-line… | 1991 |
| * | K081805 | CuffalertSummary page 1…BSK - 868.5730 Predicate Devices: Posey Cufflator - K912723 SunMed CuffAert TM - K081805 Device Description: The Easy CuffTm is simple in-line pressures monitqr which contains a c… | 2008 |
What descends from it? (7)
3 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 20 years and passes through 3 companies; a new generation was cleared every 17.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K142103 (Teleflexmedical, Inc., 2015) has gone furthest, with 3 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. 2011, 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 inflate cuffs and to measure and monitor intra-cuff pressures of endotracheal,
supraglottic airways, or tracheostomy tubes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102704: Easy Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102704
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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