510(k) · Cleared
ClearedSterile Water USP and Sterile 0.9% Normal Saline USP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laboratorios Biogalenic S.A. DE C.V. · FRO Dressing, Wound, Drug
Cleared on Mar 6, 2025 as substantially equivalent to K173276 (Medline Industries, Inc., 2018) after a 161-day review. Its family tree reaches back 7 generations to 1995. 1 of the 19 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 6, 2025
- Review
- 161 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945802 (1995). 18 ancestors in all, the oldest K935060 (1994). No later device cites it as a predicate yet. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 6 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 5 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 4 generations backK040779 Restore Wound CleanserHollister, Inc. · 2004
- 3 generations backK042084 Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005
- 2 generations backK083042 Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Recalled (Class I)
- 1 generation backK173276 Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc. · 2018 · Recalled
- This deviceK243001 Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V. · 2025
Class I recalls in this family
- K083042 Wound Flush, Sterile Water & Normal Saline2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −6 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −5 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −4 | K040779 | Restore Wound Cleanser | Hollister, Inc. | 2004 | — |
| −3 | K042084 | Bioderm Sciences Wound Healing Spray | Bioderm Sciences, Inc. | 2005 | — |
| −2 | K083042 | Wound Flush, Sterile Water & Normal Saline | Nurse Assist, Inc. | 2008 | Class I |
| −1 | K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP | Medline Industries, Inc. | 2018 | 1 |
| 0 (this device) | K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP | Laboratorios Biogalenic S.A. DE C.V. | 2025 | — |
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? (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 |
|---|---|---|---|
| * | K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPSummary page 5…evice Name : Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP 510(k) Number : K173276 Device Classification : Unclassified Product Code : FRO… | 2018 |
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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 dressing and cleaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin.
For moistening absorbent wound dressing 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/K243001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243001: Sterile Water USP and Sterile 0.9% Normal Saline USP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243001
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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