510(k) · Cleared
ClearedPrimary Care Solutions, Inc., Sterile Water and Saline for Irrigation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primary Care Solutions, Inc. · FRO Dressing, Wound, Drug
Cleared on Oct 9, 2008 as substantially equivalent to K000265 (Primary Care Solutions, Inc., 2001) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it.
- Decided
- Oct 9, 2008
- Review
- 56 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000265 (2001). 2 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK000265 Primary Care Solutions Sterile Water Device IrrigationPrimary Care Solutions, Inc. · 2001
- This deviceK082330 Primary Care Solutions, Inc., Sterile Water and Saline for IrrigationPrimary Care Solutions, Inc. · 2008
- Descendant · cites it directly · 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 · 3 generations on · 1 of its ownK213514 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK090848 Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc. · 2009
- Descendant · 4 generations on · 0 of its ownK243875 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · cites it directly4descendants
- K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016 · 2 generations on3descendants
- K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023 · 3 generations on1descendant
- K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc. · 2009 · cites it directly1descendant
- K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000265 | Primary Care Solutions Sterile Water Device Irrigation | Primary Care Solutions, Inc. | 2001 | — |
| 0 (this device) | K082330 | Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation | Primary Care Solutions, Inc. | 2008 | — |
| +1 | K141012 | Hydrocleanse Wound Care Solution | Oculus Innovative Sciences | 2014 | — |
| +2 | K161034 | Microcyn Plus Wound Care Solution | Oculus Innovative Sciences | 2016 | — |
| +3 | K213514 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. | 2023 | — |
| +1 | K090848 | Premier Sterile Saline Wound Wash, Models 210 ML, WWM | Premier Brands of America, Inc. | 2009 | — |
| +4 | K243875 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | K000265 | Primary Care Solutions Sterile Water Device IrrigationSummary page 1…rigation Class: Unclassified Reason forApplication Expanded Label Usage of Existing Device Predicate Devices: K000265, K000266 Sterile Water and Sterile Saline For Device Irrigation, Primary Care Solutions, Inc.,… | 2001 |
| * | K000266 | Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device IrrigationSummary page 1…Class: Unclassified Reason forApplication Expanded Label Usage of Existing Device Predicate Devices: K000265, K000266 Sterile Water and Sterile Saline For Device Irrigation, Primary Care Solutions, Inc.,… | 2001 |
What descends from it? (7)
3 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K141012 (Oculus Innovative Sciences, 2014) has gone furthest, with 4 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?
Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082330 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082330: Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082330
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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