510(k) · Cleared
ClearedAnscare SIMO Negative Pressure Wound Therapy (NPWT) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benq Materials Corporation · OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Cleared on May 4, 2020 as substantially equivalent to K151710 (Spiracur, Inc., 2015) after a 168-day review. Its family tree reaches back 6 generations to 2009.
- Decided
- May 4, 2020
- Review
- 168 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN080011 (2009). No later device cites it as a predicate yet.
- Root · 6 generations backDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
- 5 generations backK111393 Snap (R) Wound Care SystemSpiracur, Inc. · 2011
- 4 generations backK112341 Snap Wound Care SystemSpiracur, Inc. · 2011
- 3 generations backK132080 Snap Wound Care SystemSpiracur, Inc. · 2014
- 2 generations backK142272 SNaP Wound Care SystemSpiracur, Inc. · 2014
- 1 generation backK151710 SNaP Wound Care SystemSpiracur, Inc. · 2015
- This deviceK193185 Anscare SIMO Negative Pressure Wound Therapy (NPWT) SystemBenq Materials Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN080011 | Snap Wound Care Device | Spiracur, Inc. | 2009 | — |
| −5 | K111393 | Snap (R) Wound Care System | Spiracur, Inc. | 2011 | — |
| −4 | K112341 | Snap Wound Care System | Spiracur, Inc. | 2011 | — |
| −3 | K132080 | Snap Wound Care System | Spiracur, Inc. | 2014 | — |
| −2 | K142272 | SNaP Wound Care System | Spiracur, Inc. | 2014 | — |
| −1 | K151710 | SNaP Wound Care System | Spiracur, Inc. | 2015 | — |
| 0 (this device) | K193185 | Anscare SIMO Negative Pressure Wound Therapy (NPWT) System | Benq Materials Corporation | 2020 | — |
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 OKO? 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 OKO device
- #1 K250708 NPsealscore 15.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K151710 | SNaP Wound Care SystemSummary page 5…Number: 21 CFR 878.4683 Panel: General & Plastic Surgery Product Code: OKO 510(k) Number: K151710 Reference Device PICO Single Use Negative Pressure Wound Name: Therapy System… | 2015 |
| † | K151436 | PICO Single Use Negative Pressure Wound Therapy System | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K151710.
How does its category compare?
All OKO devicesOKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OKO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OKO
137in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OKO
No recall names OKO since 2007.
Adverse event reports per year · OKO
1in 2023
MAUDE reports naming product code OKO, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 4 | 61 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 137 | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
SIMO System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it
may promote wound healing via removal of excess exudate and infectious materials.
SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types:
* Chronic wounds
* Acute wounds
* Traumatic wounds
* Subacute and dehisced wounds
* Partial-thickness burns
* Ulcers (such as diabetic or pressure)
* Flaps and grafts
* Closed surgical incisions
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/K193185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193185: Anscare SIMO Negative Pressure Wound Therapy (NPWT) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193185
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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