510(k) · Cleared
Recalled · Class I · 2023Wound Flush, Sterile Water & Normal Saline
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nurse Assist, Inc. · FRO Dressing, Wound, Drug
Cleared on Dec 18, 2008 as substantially equivalent to K003402 (Welcon, Inc., 2001) and 3 other predicates after a 65-day review. Its family tree reaches back 5 generations to 1995. 1 of the 24 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Dec 18, 2008
- Review
- 65 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 2 (2 Class I)
- Predicates
- 5
Its longest line of descent runs back 5 generations to K945802 (1995). 16 ancestors in all, the oldest K935060 (1994). 7 later devices descend from it, 6 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- 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 backK040779 Restore Wound CleanserHollister, Inc. · 2004
- 1 generation backK042084 Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005
- This deviceK083042 Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK161311 USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9%…Strukmyer Medical, LLC · 2016
- Descendant · cites it directly · 1 of its ownK173276 Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc. · 2018 · Recalled
- Descendant · cites it directly · 1 of its ownK172486 Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline…Anexa Biomedical, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK243001 Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V. · 2025
- Descendant · cites it directly · 0 of its ownK181423 AMSure Sterile Water, and Sterile Normal Saline for Wound FlushAmsino International, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL…Strukmyer Medical, LLC · 2016 · cites it directly2descendants
- K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc. · 2018 · cites it directly1descendant
- K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium…Anexa Biomedical, Inc. · 2017 · cites it directly1descendant
- K243001Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V. · 2025 · 2 generations on0descendants
- K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushAmsino International, Inc. · 2018 · 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 | K040779 | Restore Wound Cleanser | Hollister, Inc. | 2004 | — |
| −1 | K042084 | Bioderm Sciences Wound Healing Spray | Bioderm Sciences, Inc. | 2005 | — |
| 0 (this device) | K083042 | Wound Flush, Sterile Water & Normal Saline | Nurse Assist, Inc. | 2008 | — |
| +1 | K161311 | USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium… | Strukmyer Medical, LLC | 2016 | — |
| +1 | K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP | Medline Industries, Inc. | 2018 | 1 |
| +1 | K172486 | Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9%… | Anexa Biomedical, Inc. | 2017 | — |
| +2 | K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP | Laboratorios Biogalenic S.A. DE C.V. | 2025 | — |
| +1 | K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Flush | Amsino International, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 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.
1 device in this family has a Class I recall. 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K973784 | FDA’s K973784 is Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other… Our reading of the summary gave K973784, FDA’s number for Triage Panel for Drugs of Abuse, Plus Tricyclic… (Biosite Incorporated). Its FDA name has none of the distinctive words the summary uses for the device it names, “Welcon Sterile Water and Sterile 0.9% Normal Saline”. Kept off the family tree. Summary page 1…device Product code FRO 7. Legally marketed predicate devices to which substantial equivalence is claimed: * Welcon Sterile Water and Sterile 0.9% Normal Saline - K973784 and K003402 * Dermacyn Wound Care; Oculus Innovative Sciences, Incorporated - K0601 13 * Revera Wound Care; Revalesio Corpo… | 1997 |
| * | K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…Summary page 1…oduct code FRO 7. Legally marketed predicate devices to which substantial equivalence is claimed: * Welcon Sterile Water and Sterile 0.9% Normal Saline - K973784 and K003402 * Dermacyn Wound Care; Oculus Innovative Sciences, Incorporated - K0601 13 * Revera Wound Care; Revalesio Corporation - K07… | 2001 |
| * | K060113 | Dermacyn Wound CareSummary page 1…uivalence is claimed: * Welcon Sterile Water and Sterile 0.9% Normal Saline - K973784 and K003402 * Dermacyn Wound Care; Oculus Innovative Sciences, Incorporated - K0601 13 * Revera Wound Care; Revalesio Corporation - K070463 * BioDerm Wound Spray; BioDenrn Sciences, Incorporated - K042084 *… | 2006 |
| * | K070463 | Revera Wound Care, Model MDW0060Summary page 1…le 0.9% Normal Saline - K973784 and K003402 * Dermacyn Wound Care; Oculus Innovative Sciences, Incorporated - K0601 13 * Revera Wound Care; Revalesio Corporation - K070463 * BioDerm Wound Spray; BioDenrn Sciences, Incorporated - K042084 * Blairex Wound Wash Saline, Blairex Laboratories, Incorpo… | 2008 |
| * | K042084 | Bioderm Sciences Wound Healing SpraySummary page 1…; Oculus Innovative Sciences, Incorporated - K0601 13 * Revera Wound Care; Revalesio Corporation - K070463 * BioDerm Wound Spray; BioDenrn Sciences, Incorporated - K042084 * Blairex Wound Wash Saline, Blairex Laboratories, Incorporated - unknown 8. Description of the device that is the subject of… | 2005 |
| * | — | Blairex Wound Wash Saline Named without a submission number |
What descends from it? (7)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161311 | USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL… | 2016 | 2 |
| K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP | 2018 | 1 |
| K172486 | Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium… | 2017 | 1 |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Flush | 2018 | 0 |
| K170270 | Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline | 2017 | 0 |
| K161658 | Anexa Wound Flush, Sterile Water & Sterile Normal Saline | 2016 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2023 | Class I | Z-0511-2024 | Process control | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. |
| Nov 6, 2023 | Class I | Z-0513-2024 | Process control | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K161311 (Strukmyer Medical, LLC, 2016) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K003402.
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?
For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083042 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083042: Wound Flush, Sterile Water & Normal Saline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083042
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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