510(k) · Cleared
ClearednpSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aatru Medical, LLC · QPX Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
Cleared on Aug 23, 2021 as substantially equivalent to K151710 (Spiracur, Inc., 2015) after a 452-day review. Its family tree reaches back 6 generations to 2009.
- Decided
- Aug 23, 2021
- Review
- 452 days
- Class
- Class II
- Product code
- QPX
- 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 deviceK201400 npSIMS Negative Pressure Surgical Incision Management System™…Aatru Medical, LLC · 2021
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) | K201400 | npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ | Aatru Medical, LLC | 2021 | — |
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 QPX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 4…apy. Regulatory Class: Class II Product Code/Panel: QPX/General and Plastic Surgery Devices Predicate Device K151710 Spiracur SNaP Wound Care System Reference Device K180698 Smith & Nephew Medical PICO7 Single Use Negative Pressure Wound… | 2015 |
| † | K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | 2018 |
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 12 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 QPX devicesQPX Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QPX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QPX
Too few QPX 510(k)s in any year since 2007 to give a median.
Recalls per year · QPX
No recall names QPX since 2007.
Adverse event reports per year · QPX
No MAUDE report names QPX since 2007.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Negative Pressure Surgical Incision Management System (npSIMS)™ is indicated for patients who may benefit from
wound management via application of negative pressure, as the device may promote wound healing through the removal
of excess exudate, infectious material and tissue debris. The npSIMS is indicated for removal of small amounts of exudate
from 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/K201400 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201400: npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201400
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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