510(k) · Cleared
ClearedAqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ls Scientific Inc. D.B.A. Kse Scientific · FRO Dressing, Wound, Drug
Cleared on Jun 23, 2017 as substantially equivalent to K083042 (Nurse Assist, Inc., 2008) and 1 other predicate after a 147-day review. Its family tree reaches back 6 generations to 1995. 1 of the 18 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 23, 2017
- Review
- 147 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945802 (1995). 17 ancestors in all, the oldest K935060 (1994). No later device cites it as a predicate yet. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- 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 backK040779 Restore Wound CleanserHollister, Inc. · 2004
- 2 generations backK042084 Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005
- 1 generation backK083042 Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Recalled (Class I)
- This deviceK170270 Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal SalineLs Scientific Inc. D.B.A. Kse Scientific · 2017
Class I recalls in this family
- K083042 Wound Flush, Sterile Water & Normal Salinedirect predicate · 2008
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 | K040779 | Restore Wound Cleanser | Hollister, Inc. | 2004 | — |
| −2 | K042084 | Bioderm Sciences Wound Healing Spray | Bioderm Sciences, Inc. | 2005 | — |
| −1 | K083042 | Wound Flush, Sterile Water & Normal Saline | Nurse Assist, Inc. | 2008 | Class I |
| 0 (this device) | K170270 | Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline | Ls Scientific Inc. D.B.A. Kse Scientific | 2017 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K083042 | Wound Flush, Sterile Water & Normal SalineSummary page 4…rketed predicate devices to which substantial equivalence is claimed: • Wound Flush, Sterile Water & Normal Saline; Nurse Assist, Incorporated - K083042 • Welcon Sterile Water for Device Irrigation, Welcon Sterile 0.9% Normal Saline; Nurse Assist, Incorpora… | 2008 |
| * | K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…Summary page 4…orporated - K083042 • Welcon Sterile Water for Device Irrigation, Welcon Sterile 0.9% Normal Saline; Nurse Assist, Incorporated - K003402 Page 5-1 KSE Scientific === Page 5 =… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K083042.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
OTC: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skins. Not for injection.
Rx: 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. Not for injection.
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/K170270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170270: Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170270
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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