510(k) · Cleared
ClearedClyra Wound Irrigation Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clyra Medical Technologies, Inc. · FRO Dressing, Wound, Drug
Cleared on Sep 20, 2019 as substantially equivalent to K133542 (Innovacyn, Inc., 2014) after a 476-day review. Its family tree reaches back 10 generations to 1992. 5 later devices descend from it.
- Decided
- Sep 20, 2019
- Review
- 476 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K914579 (1992). 44 ancestors in all, the oldest K830708 (1983). 5 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 6 generations between
- 3 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 2 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 1 generation backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- This deviceK181428 Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK202071 SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020
- Descendant · 2 generations on · 3 of its ownK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
- Descendant · 3 generations on · 2 of its ownK221504 BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022
- Descendant · 4 generations on · 0 of its ownK253996 BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026
- Descendant · 4 generations on · 0 of its ownK253445 BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026
Show all 10 generations
- Root · 10 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 9 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 8 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 7 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 6 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 5 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 4 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 3 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 2 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 1 generation backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- This deviceK181428 Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020 · cites it directly4descendants
- K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022 · 2 generations on3descendants
- K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022 · 3 generations on2descendants
- K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026 · 4 generations on0descendants
- K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −9 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −8 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −7 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −6 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −5 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −4 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −3 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −2 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| −1 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| 0 (this device) | K181428 | Clyra Wound Irrigation Solution | Clyra Medical Technologies, Inc. | 2019 | — |
| +1 | K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020 | — |
| +2 | K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022 | — |
| +3 | K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | 2022 | — |
| +4 | K253996 | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | 2026 | — |
| +4 | K253445 | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) | Bd | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 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 |
|---|---|---|---|
| * | K133542 | Puracyn Plus Skin and Wound Our reading of the summary gave K133452, FDA’s number for Emerge Medical Small Fragment Locked Plating System (Emerge Medical). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Puracyn Plus Skin and Wound Care”. | 2014 |
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 |
|---|---|---|---|
| K202071 | SURGIPHOR Wound Irrigation System | 2020 | 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 27 years and passes through 9 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 44 ancestors have a recall of any class.
- Of its descendants, K202071 (Orthophor, LLC, 2020) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K133542.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
Clyra Wound Irrigation Solution is intended for use by healthcare professionals for cleansing, irrigating, moistening and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic ulcers, stasis ulcers, abrasions and minor skin irritations, post surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings.
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/K181428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181428: Clyra Wound 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/K181428
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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