510(k) · Cleared
ClearedBrennen Medical Sterile Saline Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brennen Medical, Inc. · KMF Bandage, Liquid
Cleared on Jan 10, 1994 after an 82-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 34 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it.
- Decided
- Jan 10, 1994
- Review
- 82 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 1 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- This deviceK935060 Brennen Medical Sterile Saline SolutionBrennen Medical, Inc. · 1994
- Descendant · cites it directly · 32 of its ownK972185 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium ChlorideSteripak, Ltd. · 1998
- Descendant · 2 generations on · 29 of its ownK040683 Bioderm Sciences Wound DressingBioderm Sciences, Inc. · 2004
- Descendant · 3 generations on · 14 of its ownK063063 Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 3 generations on · 13 of its ownK083355 Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML…Blairex Laboratories, Inc. · 2008
- Descendant · 3 generations on · 13 of its ownK042084 Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K083042 Wound Flush, Sterile Water & Normal Saline4 generations on · 2008
Most influential descendants
Showing 5 of 33 · See all- K97218520 ML Normal Saline Topical Solution, 0.9% W/V Sodium ChlorideSteripak, Ltd. · 1998 · cites it directly32descendants
- K040683Bioderm Sciences Wound DressingBioderm Sciences, Inc. · 2004 · 2 generations on29descendants
- K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC · 2007 · 3 generations on14descendants
- K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc. · 2008 · 3 generations on13descendants
- K042084Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935060 | Brennen Medical Sterile Saline Solution | Brennen Medical, Inc. | 1994 | — |
| +1 | K972185 | 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium Chloride | Steripak, Ltd. | 1998 | — |
| +2 | K040683 | Bioderm Sciences Wound Dressing | Bioderm Sciences, Inc. | 2004 | — |
| +3 | K063063 | Silvacide Skin & Wound Moisturizing Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +3 | K083355 | Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 | Blairex Laboratories, Inc. | 2008 | — |
| +3 | K042084 | Bioderm Sciences Wound Healing Spray | Bioderm Sciences, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 1 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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 KMF device
- #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972185 | 20 ML Normal Saline Topical Solution, 0.9% W/V Sodium Chloride | 1998 | 32 |
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 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K972185 (Steripak, Ltd., 1998) has gone furthest, with 32 descendants of its own.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KMF
213in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMF
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMF
12in 2025
MAUDE reports naming product code KMF, 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 | 2 | — | 1 | 6 |
| 2008 | 3 | 35 | 0 | 2 |
| 2009 | 3 | 213 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 2 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 2 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K935060 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935060: Brennen Medical Sterile Saline Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935060
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026