510(k) · Cleared
ClearedNPseal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guard Medical, Inc. · OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Cleared on May 14, 2021 as substantially equivalent to K200305 (Guard Medical, Inc., 2020) after a 28-day review. Its family tree reaches back 7 generations to 2009. 5 later devices descend from it.
- Decided
- May 14, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN080011 (2009). 5 later devices descend from it, 1 citing it directly.
- Root · 7 generations backDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
- 6 generations backK111393 Snap (R) Wound Care SystemSpiracur, Inc. · 2011
- 5 generations backK112341 Snap Wound Care SystemSpiracur, Inc. · 2011
- 4 generations backK132080 Snap Wound Care SystemSpiracur, Inc. · 2014
- 3 generations backK142272 SNaP Wound Care SystemSpiracur, Inc. · 2014
- 2 generations backK151710 SNaP Wound Care SystemSpiracur, Inc. · 2015
- 1 generation backK200305 NPsealGuard Medical, Inc. · 2020
- This deviceK211130 NPsealGuard Medical, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK212971 NPsealGuard Medical, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK240244 NPseal (Small, Medium, Large)Guard Medical, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK241522 NPseal (20 and 25)Guard Medical, Inc. · 2024
- Descendant · 4 generations on · 1 of its ownK250708 NPsealGuard Medical, Inc. · 2025
- Descendant · 5 generations on · 0 of its ownK251156 NPsealGuard Medical, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K212971NPsealGuard Medical, Inc. · 2022 · cites it directly4descendants
- K240244NPseal (Small, Medium, Large)Guard Medical, Inc. · 2024 · 2 generations on3descendants
- K241522NPseal (20 and 25)Guard Medical, Inc. · 2024 · 3 generations on2descendants
- K250708NPsealGuard Medical, Inc. · 2025 · 4 generations on1descendant
- K251156NPsealGuard Medical, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN080011 | Snap Wound Care Device | Spiracur, Inc. | 2009 | — |
| −6 | K111393 | Snap (R) Wound Care System | Spiracur, Inc. | 2011 | — |
| −5 | K112341 | Snap Wound Care System | Spiracur, Inc. | 2011 | — |
| −4 | K132080 | Snap Wound Care System | Spiracur, Inc. | 2014 | — |
| −3 | K142272 | SNaP Wound Care System | Spiracur, Inc. | 2014 | — |
| −2 | K151710 | SNaP Wound Care System | Spiracur, Inc. | 2015 | — |
| −1 | K200305 | NPseal | Guard Medical, Inc. | 2020 | — |
| 0 (this device) | K211130 | NPseal | Guard Medical, Inc. | 2021 | — |
| +1 | K212971 | NPseal | Guard Medical, Inc. | 2022 | — |
| +2 | K240244 | NPseal (Small, Medium, Large) | Guard Medical, Inc. | 2024 | — |
| +3 | K241522 | NPseal (20 and 25) | Guard Medical, Inc. | 2024 | — |
| +4 | K250708 | NPseal | Guard Medical, Inc. | 2025 | — |
| +5 | K251156 | NPseal | Guard Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 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 |
|---|---|---|---|
| * | K200305 | NPsealSummary page 4…Classification: Class II Product Code: OKO (21 CFR 878.4683) Predicate Device: NPseal (K200305) 1.4 Device Description The NPseal Negative Pressure Advanced System is a single-use device that includes a… | 2020 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212971 | NPseal | 2022 | 4 |
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 12 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K212971 (Guard Medical, Inc., 2022) has gone furthest, with 4 descendants of its own.
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. 2021, 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?
The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates 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/K211130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211130: NPseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211130
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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