510(k) · Cleared
ClearedSimex Subglottic Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simex Medizintechnik GmbH · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Sep 22, 2014 as substantially equivalent to K061205 (Medela AG, 2006) and 2 other predicates after a 131-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 22, 2014
- Review
- 131 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K945062 (1995). 16 ancestors in all, the oldest K933902 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 4 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 3 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- 2 generations backK080357 Medela Invia Wound TherapyMedela AG · 2008 · Recalled
- 1 generation backK113291 Simex Negative Pressure Wound Therapy Powered Suction Pumps Series…Simex Medizintechnik GmbH · 2012
- This deviceK141255 Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH · 2014
- Descendant · cites it directly · 2 of its ownK150157 AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK180991 AG 100sHospitech Respiration, Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK221477 AG100sHospitech Respiration, Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −4 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −3 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| −2 | K080357 | Medela Invia Wound Therapy | Medela AG | 2008 | 1 |
| −1 | K113291 | Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200… | Simex Medizintechnik GmbH | 2012 | — |
| 0 (this device) | K141255 | Simex Subglottic Aspiration System | Simex Medizintechnik GmbH | 2014 | — |
| +1 | K150157 | AnapnoGuard 100 Respiratory Guard System | Hospitech Respiration, Ltd. | 2016 | — |
| +2 | K180991 | AG 100s | Hospitech Respiration, Ltd. | 2018 | — |
| +3 | K221477 | AG100s | Hospitech Respiration, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 BTA? 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 BTA device
- #1 K222547 Electric nasal aspiratorscore 20.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K061205 | Medela Vario 8/18/CI Secretion & Surgical AspiratorSummary page 4…Medela® Vario 8/18/ci Secretion & Surgical SIMEX EX200 and EX300 Negative Pressure Aspirator System Wound Therapy System 510(k) K061205 Medela AG 510(k) K113291 SIMEX Medizitechnik GmbH Product Code BTA Prod… | 2006 |
| * | K113291 | Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…Summary page 4…SIMEX EX200 and EX300 Negative Pressure Aspirator System Wound Therapy System 510(k) K061205 Medela AG 510(k) K113291 SIMEX Medizitechnik GmbH Product Code BTA Product Code OMP SIMEX Suction Pumps 510(k) K061133 N… | 2012 |
| * | K061133 | Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SSummary page 4…Medela AG 510(k) K113291 SIMEX Medizitechnik GmbH Product Code BTA Product Code OMP SIMEX Suction Pumps 510(k) K061133 Novaspine LLC Product Code BTA Indications for Use: The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicat… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150157 | AnapnoGuard 100 Respiratory Guard System | 2016 | 2 |
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 19 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 6 of the 16 ancestors have a recall of any class.
- Of its descendants, K150157 (Hospitech Respiration, Ltd., 2016) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K061205.
How does its category compare?
All BTA devicesBTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · BTA
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · BTA
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTA
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTA
13in 2025
MAUDE reports naming product code BTA, 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 | 1 | — | 1 | 13 |
| 2008 | 3 | 135 | 3 | 5 |
| 2009 | 2 | — | 0 | 14 |
| 2010 | 2 | — | 3 | 178 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 3 | 45 | 0 | 18 |
| 2014 | 3 | 91 | 0 | 399 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 149 | 0 | 25 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 4 | 125 | 0 | 17 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 1 | 9 |
| 2022 | 3 | 58 | 0 | 7 |
| 2023 | 4 | 265 | 0 | 8 |
| 2024 | 5 | 131 | 0 | 13 |
| 2025 | 6 | 87 | 0 | 13 |
| 2026 | 7 | 89 | 0 | — |
What is it indicated for?
The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicated for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at the patient's bedside.
Generally, the SIMEX Subglottic Aspiration System is intended for removing subglottic secretions from the patient's airway above the endotracheal or tracheal cuff using intermittent suction when used in ICU and acute care settings where the duration of mechanical ventilation is limited to a maximum of 4 weeks.
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/K141255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141255: Simex Subglottic Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141255
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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