510(k) · Cleared
ClearedBactisure Wound Lavage
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 Jan 23, 2020 as substantially equivalent to K161165 (Next Science, LLC, 2016) after a 147-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jan 23, 2020
- Review
- 147 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945802 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 5 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 4 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 3 generations backK060113 Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006
- 2 generations backK072876 Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2008
- 1 generation backK161165 Next Science Irrigation SolutionNext Science, LLC · 2016
- This deviceK192349 Bactisure Wound LavageNext Science, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −5 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −4 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −3 | K060113 | Dermacyn Wound Care | Oculus Innovative Sciences, Inc. | 2006 | — |
| −2 | K072876 | Prontosan Wound Irrigation Solution | B.Braun Medical, Inc. | 2008 | — |
| −1 | K161165 | Next Science Irrigation Solution | Next Science, LLC | 2016 | — |
| 0 (this device) | K192349 | Bactisure Wound Lavage | Next Science, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K161165 | Next Science Irrigation SolutionSummary page 4…e: FQH, FRO Classification: Class II, unclassified CFR: 21 CFR 880.5475 Predicate Device: Next Science™ Irrigation Solution, K161165 Indications for Use: Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus or Pulsavac Plus AC lavage systems and i… | 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 25 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K161165.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus or Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192349: Bactisure Wound Lavage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192349
Report an extraction error
Are you the manufacturer?
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