510(k) · Cleared
ClearedNext Science Irrigation Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Next Science, LLC · FQH Lavage, Jet
Cleared on Sep 7, 2016 as substantially equivalent to K072876 (B.Braun Medical, Inc., 2008) after a 135-day review. Its family tree reaches back 5 generations to 1995. 4 later devices descend from it.
- Decided
- Sep 7, 2016
- Review
- 135 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945802 (1995). 6 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 4 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 3 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 2 generations backK060113 Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006
- 1 generation backK072876 Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2008
- This deviceK161165 Next Science Irrigation SolutionNext Science, LLC · 2016
- Descendant · cites it directly · 0 of its ownK220759 Armis VeriCyn Wound WashArmis Biopharma, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK203446 TorrentX Wound WashNext Science, LLC · 2021
- Descendant · cites it directly · 0 of its ownK203835 MIS SolutionNext Science, LLC · 2021
- Descendant · cites it directly · 0 of its ownK192349 Bactisure Wound LavageNext Science, LLC · 2020
Most influential descendants
Showing 4 of 4 · See all- K220759Armis VeriCyn Wound WashArmis Biopharma, Inc. · 2023 · cites it directly0descendants
- K203446TorrentX Wound WashNext Science, LLC · 2021 · cites it directly0descendants
- K203835MIS SolutionNext Science, LLC · 2021 · cites it directly0descendants
- K192349Bactisure Wound LavageNext Science, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −4 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −3 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −2 | K060113 | Dermacyn Wound Care | Oculus Innovative Sciences, Inc. | 2006 | — |
| −1 | K072876 | Prontosan Wound Irrigation Solution | B.Braun Medical, Inc. | 2008 | — |
| 0 (this device) | K161165 | Next Science Irrigation Solution | Next Science, LLC | 2016 | — |
| +1 | K220759 | Armis VeriCyn Wound Wash | Armis Biopharma, Inc. | 2023 | — |
| +1 | K203446 | TorrentX Wound Wash | Next Science, LLC | 2021 | — |
| +1 | K203835 | MIS Solution | Next Science, LLC | 2021 | — |
| +1 | K192349 | Bactisure Wound Lavage | Next Science, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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 FQH? 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 FQH device
- #1 K253996 BD Surgiphor™ Antimicrobial Irrigation System…score 14.8 · 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? (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 |
|---|---|---|---|
| * | K072876 | Prontosan Wound Irrigation SolutionSummary page 4…Dressing, Wound, Drug Product Code: FRO and FQH Classification: Unclassified Predicate Device: Prontosan Wound Irrigation Solution (K072876) Reference Device: Atteris Antimicrobial Skin & Wound Cleanser (K160192). This device is refer… | 2008 |
| † | K160192 | Atteris Antimicrobial Skin & Wound Cleanser | 2016 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K220759 (Armis Biopharma, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K072876.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FQH
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FQH
410in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FQH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQH
835in 2025
MAUDE reports naming product code FQH, 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 | 1 | — | 13 | 10 |
| 2008 | 0 | — | 0 | 27 |
| 2009 | 3 | 240 | 1 | 70 |
| 2010 | 0 | — | 7 | 135 |
| 2011 | 2 | — | 0 | 83 |
| 2012 | 1 | — | 0 | 133 |
| 2013 | 0 | — | 0 | 134 |
| 2014 | 0 | — | 0 | 194 |
| 2015 | 1 | — | 0 | 116 |
| 2016 | 1 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 243 |
| 2018 | 0 | — | 0 | 317 |
| 2019 | 0 | — | 2 | 328 |
| 2020 | 3 | 130 | 0 | 393 |
| 2021 | 1 | — | 0 | 398 |
| 2022 | 4 | 136 | 0 | 171 |
| 2023 | 3 | 410 | 0 | 333 |
| 2024 | 0 | — | 0 | 425 |
| 2025 | 0 | — | 0 | 835 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Next Science Irrigation Solution is to be used with a jet lavage system and is indicated for use in cleansing and removal of debris, including microorganisms, from wounds.
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/K161165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161165: Next Science Irrigation Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161165
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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