510(k) · Cleared
ClearedEcocel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polichem S.A · KMF Bandage, Liquid
Cleared on Aug 7, 2009 as substantially equivalent to K002338 (Closure Medical Corp., 2001) and 1 other predicate after a 295-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Aug 7, 2009
- Review
- 295 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955103 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK955103 3M NO Sting Barrier Film3M Medical Products Group · 1996
- 1 generation backK023163 Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS…Medlogic Global Limited · 2003
- This deviceK083087 EcocelPolichem S.A · 2009
- Descendant · cites it directly · 0 of its ownK120059 Liquid BandageChesson Laboratory Associates, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120059Liquid BandageChesson Laboratory Associates, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955103 | 3M NO Sting Barrier Film | 3M Medical Products Group | 1996 | — |
| −1 | K023163 | Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS 0020 | Medlogic Global Limited | 2003 | — |
| 0 (this device) | K083087 | Ecocel | Polichem S.A | 2009 | — |
| +1 | K120059 | Liquid Bandage | Chesson Laboratory Associates, Inc. | 2012 | — |
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 |
|---|---|---|
| 2012 | 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 KMF? 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? (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 |
|---|---|---|---|
| * | K002338 | Liquiderm Liquid Adhesive BandageSummary page 1…gns of nail dystrophy (i.e. nail splitting and fragility). Predicate Devices: Ecocel is substantially equivalent to predicate devices, Liquiderm, Closure Medical Corp. (K002338) and LiquiShield S, MedLogic Global Ltd. (K023 163). Technological Characteristics Polichem has submitted summaries of preclinic… | 2001 |
| * | K023163 | Liquishield-S (0.7G), Model LS 0010, Liquishield-S (2.0G), Model LS 0020Summary page 1…gility). Predicate Devices: Ecocel is substantially equivalent to predicate devices, Liquiderm, Closure Medical Corp. (K002338) and LiquiShield S, MedLogic Global Ltd. (K023 163). Technological Characteristics Polichem has submitted summaries of preclinical studies, including biocompatibility and laborato… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120059 | Liquid Bandage | 2012 | 0 |
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120059 (Chesson Laboratory Associates, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K002338.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Ecocel® is a hydrosoluble lacquer indicated to protect intact or damaged nails from the effects of moisture, friction (rubbing) or shear (tearing), relieving symptoms and signs of nail dystrophy (i.e. nail-splitting and fragility).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083087: Ecocel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083087
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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