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 26, 2020 as substantially equivalent to K151710 (Spiracur, Inc., 2015) after a 110-day review. Its family tree reaches back 6 generations to 2009. 6 later devices descend from it.
- Decided
- May 26, 2020
- Review
- 110 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN080011 (2009). 6 later devices descend from it, 1 citing it directly.
- 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 deviceK200305 NPsealGuard Medical, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK211130 NPsealGuard Medical, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK212971 NPsealGuard Medical, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK240244 NPseal (Small, Medium, Large)Guard Medical, Inc. · 2024
- Descendant · 4 generations on · 2 of its ownK241522 NPseal (20 and 25)Guard Medical, Inc. · 2024
- Descendant · 5 generations on · 1 of its ownK250708 NPsealGuard Medical, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K211130NPsealGuard Medical, Inc. · 2021 · cites it directly5descendants
- K212971NPsealGuard Medical, Inc. · 2022 · 2 generations on4descendants
- K240244NPseal (Small, Medium, Large)Guard Medical, Inc. · 2024 · 3 generations on3descendants
- K241522NPseal (20 and 25)Guard Medical, Inc. · 2024 · 4 generations on2descendants
- K250708NPsealGuard Medical, Inc. · 2025 · 5 generations on1descendant
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) | K200305 | NPseal | Guard Medical, Inc. | 2020 | — |
| +1 | K211130 | NPseal | Guard Medical, Inc. | 2021 | — |
| +2 | K212971 | NPseal | Guard Medical, Inc. | 2022 | — |
| +3 | K240244 | NPseal (Small, Medium, Large) | Guard Medical, Inc. | 2024 | — |
| +4 | K241522 | NPseal (20 and 25) | Guard Medical, Inc. | 2024 | — |
| +5 | K250708 | NPseal | Guard Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K151710 | SNaP Wound Care SystemSummary page 4…ative pressure wound therapy. (21 CFR 878.4683) Regulatory Class: II Product Code: OKO III. PREDICATE & REFERENCE DEVICES Predicate Device: SNaP Wound Care System, K151710 Reference Device: PICO Single Use Negative Pressure Wound Therapy System, K180618 IV. DEVICE DESCRIPTION The NPseal Negative… | 2015 |
| † | K180618 | PICO Single Use Negative Pressure Wound Therapy System | 2018 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211130 | NPseal | 2021 | 5 |
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.
- Of its descendants, K211130 (Guard Medical, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 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?
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 as stated in the FDA summary.
https://510kreport.com/device/K200305 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200305: NPseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200305
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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