510(k) · Cleared
ClearedAG100s
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 Dec 29, 2022 as substantially equivalent to K180991 (Hospitech Respiration, Ltd., 2018) and 1 other predicate after a 220-day review. Its family tree reaches back 8 generations to 1995. 4 of the 36 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 29, 2022
- Review
- 220 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K945062 (1995). 35 ancestors in all, the oldest K791045 (1979). No later device cites it as a predicate yet. 4 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 7 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 6 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- 5 generations backK080357 Medela Invia Wound TherapyMedela AG · 2008 · Recalled
- 4 generations backK113291 Simex Negative Pressure Wound Therapy Powered Suction Pumps Series…Simex Medizintechnik GmbH · 2012
- 3 generations backK141255 Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH · 2014
- 2 generations backK150157 AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd. · 2016
- 1 generation backK180991 AG 100sHospitech Respiration, Ltd. · 2018
- This deviceK221477 AG100sHospitech Respiration, Ltd. · 2022
Class I recalls in this family
- K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal…5 generations back · 2000
- K961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy5 generations back · 1996
- K961840 Rusch Oral/Nasal Tracheal Tube, Plain…5 generations back · 1996
- K931163 Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye5 generations back · 1993
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −7 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −6 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| −5 | K080357 | Medela Invia Wound Therapy | Medela AG | 2008 | 1 |
| −4 | K113291 | Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200… | Simex Medizintechnik GmbH | 2012 | — |
| −3 | K141255 | Simex Subglottic Aspiration System | Simex Medizintechnik GmbH | 2014 | — |
| −2 | K150157 | AnapnoGuard 100 Respiratory Guard System | Hospitech Respiration, Ltd. | 2016 | — |
| −1 | K180991 | AG 100s | Hospitech Respiration, Ltd. | 2018 | — |
| 0 (this device) | K221477 | AG100s | Hospitech Respiration, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 1 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 2 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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.
4 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? (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 |
|---|---|---|---|
| * | K180991 | AG 100sSummary page 4…Review Panel: Anesthesiology 5.3 PREDICATE DEVICES Predicate Device 1 (Primary) • AG100s, by Hospitech Respiration Ltd., Product code BSK cleared Under: K180991. Predicate Device 2 (Secondary) • IntelliCuff, manufactured by Hamilton Medical AG., cleared under K150893; Product Co… | 2018 |
| * | K150893 | IntelliCuffSummary page 4…h Respiration Ltd., Product code BSK cleared Under: K180991. Predicate Device 2 (Secondary) • IntelliCuff, manufactured by Hamilton Medical AG., cleared under K150893; Product Code: BSK. 5.4 DEVICE DESCRIPTION The AG100s system is comprised of the following main components:… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K993786Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphyRusch Intl. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 13 Class I recalls
- K961837Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · 5 generations back · ◆ in the 1996 ancestors bar of FIG. 132 Class I recalls
- K961840Rusch Oral/Nasal Tracheal Tube, Plain Magill/MurphyRusch Intl. · 1996 · 5 generations back · ◆ in the 1996 ancestors bar of FIG. 124 Class I recalls
- K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 1993 · 5 generations back · ◆ in the 1993 ancestors bar of FIG. 112 Class I recalls
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 14 of the 35 ancestors have a recall of any class; 4 have a Class I recall.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation. 1. When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user. 2. When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user…
Read the full statement (148 words)
The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation.
1. When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user.
2. When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff.
3. When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the tube's cuff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221477: AG100s.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221477
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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