510(k) · Cleared
ClearedWound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blairex Laboratories, Inc. · FRO Dressing, Wound, Drug
Cleared on Dec 29, 2008 as substantially equivalent to K073610 (Swiss American Products, Inc., 2008) and 5 other predicates after a 46-day review. Its family tree reaches back 5 generations to 1992. 13 later devices descend from it.
- Decided
- Dec 29, 2008
- Review
- 46 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K914579 (1992). 34 ancestors in all, the oldest K890354 (1989). 13 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 4 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 3 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 2 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 1 generation backK063063 Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC · 2007
- This deviceK083355 Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML…Blairex Laboratories, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
- Descendant · 2 generations on · 3 of its ownK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
- Descendant · 2 generations on · 1 of its ownK243415 Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025
- Descendant · 3 generations on · 1 of its ownK213514 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014 · cites it directly8descendants
- K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · 2 generations on4descendants
- K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016 · 2 generations on3descendants
- K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025 · 2 generations on1descendant
- K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −4 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −3 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −2 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −1 | K063063 | Silvacide Skin & Wound Moisturizing Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| 0 (this device) | K083355 | Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 | Blairex Laboratories, Inc. | 2008 | — |
| +1 | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 | — |
| +2 | K141012 | Hydrocleanse Wound Care Solution | Oculus Innovative Sciences | 2014 | — |
| +2 | K161034 | Microcyn Plus Wound Care Solution | Oculus Innovative Sciences | 2016 | — |
| +2 | K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | 2025 | — |
| +3 | K213514 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (6)
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 |
|---|---|---|---|
| * | K073610 | Elta Advanced Wound WashSummary page 2…uding the removal of foreign material such as dirt and debris. 6. Predicate Devices Elta Advanced Wound Wash; Medical Molecular Therapeutics LLC [K0736 10] BioDerm Wound Solution; BioDerm Wound Sciences, Inc. [K040683] Silvion Antibacterial Silver Skin & Wound… | 2008 |
| * | K040683 | Bioderm Sciences Wound DressingSummary page 2…. Predicate Devices Elta Advanced Wound Wash; Medical Molecular Therapeutics LLC [K0736 10] BioDerm Wound Solution; BioDerm Wound Sciences, Inc. [K040683] Silvion Antibacterial Silver Skin & Wound Moisturizing Solution; Medical Molecular Therapeutics LLC [K063… | 2004 |
| * | K063063 | Silvacide Skin & Wound Moisturizing SolutionSummary page 2…ution; BioDerm Wound Sciences, Inc. [K040683] Silvion Antibacterial Silver Skin & Wound Moisturizing Solution; Medical Molecular Therapeutics LLC [K063063] Silvaklenz Antibacterial Silver Skin & Wound Cleanser; Medical Molecular Therapeutics LLC [K063069]… | 2007 |
| * | K063069 | Silvaklenz Skin and Wound Clenser SolutionSummary page 2…Medical Molecular Therapeutics LLC [K063063] Silvaklenz Antibacterial Silver Skin & Wound Cleanser; Medical Molecular Therapeutics LLC [K063069] Revera Wound Care; Revalesio Corporation [K070463] Restore Wound Cleanser; Hollister Incorporated [K04… | 2007 |
| * | K070463 | Revera Wound Care, Model MDW0060Summary page 2…Silvaklenz Antibacterial Silver Skin & Wound Cleanser; Medical Molecular Therapeutics LLC [K063069] Revera Wound Care; Revalesio Corporation [K070463] Restore Wound Cleanser; Hollister Incorporated [K040779] 7. Intended Use / Indications for Use Wound… | 2008 |
| * | K040779 | Restore Wound CleanserSummary page 2…ecular Therapeutics LLC [K063069] Revera Wound Care; Revalesio Corporation [K070463] Restore Wound Cleanser; Hollister Incorporated [K040779] 7. Intended Use / Indications for Use Wound Wash Saline® is intended to be used for cleansing dermal wounds. The… | 2004 |
What descends from it? (13)
See all 134 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 16 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K131848 (Puricore, Inc., 2014) has gone furthest, with 8 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
To cleanse wounds, scrapes, and minor burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083355: Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083355
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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