510(k) · Cleared
ClearedSimex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and Sim-EX300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simex Medizintechnik GmbH · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Aug 30, 2012 as substantially equivalent to K112458 (Medica-Rents Co., Ltd., 2012) and 4 other predicates after a 296-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Aug 30, 2012
- Review
- 296 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K945062 (1995). 15 ancestors in all, the oldest K933902 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 3 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 2 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- 1 generation backK080357 Medela Invia Wound TherapyMedela AG · 2008 · Recalled
- This deviceK113291 Simex Negative Pressure Wound Therapy Powered Suction Pumps Series…Simex Medizintechnik GmbH · 2012
- Descendant · cites it directly · 3 of its ownK141255 Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH · 2014
- Descendant · 2 generations on · 2 of its ownK150157 AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK180991 AG 100sHospitech Respiration, Ltd. · 2018
- Descendant · 4 generations on · 0 of its ownK221477 AG100sHospitech Respiration, Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH · 2014 · cites it directly3descendants
- K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd. · 2016 · 2 generations on2descendants
- K180991AG 100sHospitech Respiration, Ltd. · 2018 · 3 generations on1descendant
- K221477AG100sHospitech Respiration, Ltd. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −3 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −2 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| −1 | K080357 | Medela Invia Wound Therapy | Medela AG | 2008 | 1 |
| 0 (this device) | K113291 | Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200… | Simex Medizintechnik GmbH | 2012 | — |
| +1 | K141255 | Simex Subglottic Aspiration System | Simex Medizintechnik GmbH | 2014 | — |
| +2 | K150157 | AnapnoGuard 100 Respiratory Guard System | Hospitech Respiration, Ltd. | 2016 | — |
| +3 | K180991 | AG 100s | Hospitech Respiration, Ltd. | 2018 | — |
| +4 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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 OMP? 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 OMP device
- #1 K260646 Renasys Edge (66803126)score 15.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K112458 | Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System Cleared while this submission was under review Summary page 3…a comparison of technological characteristics. Table 1 Comparison Summary of Technological Characteristics Feature Predicate: K1 12458, SIM EX200 and PRO-I, PRO-Il and PRO-Ill NPWT pumps SIM EX3… | 2012 |
| * | K062456 | Novaspine Powered Suction Pump Pro-1Summary page 1…112458 Prospera PRO-I, PRO-Il and PRO-Ill NovaSpine K062456 PRO-I Kinetic Concepts K971548 AmbuVAC Medela… | 2006 |
| * | K971548 | AmbuvacSummary page 1…PRO-Il and PRO-Ill NovaSpine K062456 PRO-I Kinetic Concepts K971548 AmbuVAC Medela K080357 Invia Liberty Blue… | 1997 |
| * | K080357 | Medela Invia Wound TherapySummary page 1…K062456 PRO-I Kinetic Concepts K971548 AmbuVAC Medela K080357 Invia Liberty Blue Sky Medical Group, K042134 Versatile I Wound… | 2008 |
| * | K042134 | Versatile 1 Wound Vacuum SystemSummary page 1…K971548 AmbuVAC Medela K080357 Invia Liberty Blue Sky Medical Group, K042134 Versatile I Wound Inc. Vacuum System… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141255 | Simex Subglottic Aspiration System | 2014 | 3 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 6 of the 15 ancestors have a recall of any class.
- Of its descendants, K141255 (Simex Medizintechnik GmbH, 2014) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K112458.
How does its category compare?
All OMP devicesOMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OMP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMP
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMP
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMP
140in 2025
MAUDE reports naming product code OMP, 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 | 6 | 113 | 0 | 1 |
| 2008 | 8 | 98 | 0 | 1 |
| 2009 | 8 | 87 | 7 | 79 |
| 2010 | 6 | 97 | 3 | 80 |
| 2011 | 6 | 123 | 0 | 130 |
| 2012 | 11 | 292 | 1 | 97 |
| 2013 | 11 | 84 | 2 | 169 |
| 2014 | 10 | 179 | 4 | 229 |
| 2015 | 20 | 189 | 1 | 378 |
| 2016 | 19 | 146 | 2 | 398 |
| 2017 | 11 | 137 | 0 | 368 |
| 2018 | 13 | 214 | 0 | 422 |
| 2019 | 15 | 249 | 1 | 994 |
| 2020 | 6 | 179 | 0 | 3,664 |
| 2021 | 9 | 238 | 0 | 1,422 |
| 2022 | 10 | 229 | 0 | 258 |
| 2023 | 8 | 291 | 0 | 143 |
| 2024 | 9 | 181 | 2 | 135 |
| 2025 | 5 | 127 | 0 | 140 |
| 2026 | 9 | 141 | 0 | — |
What is it indicated for?
The SIMEX Negative Pressure Wound Therapy System is indicated for patients that would benefit from a suction device particularly as the device may promote wound healing by removal of wound exudate, debris, and infectious material or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from the patient's airway or respiratory support system. The SIM EX200 and SIM EX300 Negative Pressure Wound Therapy may be used during surgery or at the patient's bedside.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113291: Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and Sim-EX300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113291
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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