510(k) · Cleared
ClearedRochal Bioshield Silicone Film
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rochal Industries, LLC · KMF Bandage, Liquid
Cleared on Jun 27, 2019 as substantially equivalent to K131384 (Kericure, Inc., 2014) after a 272-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jun 27, 2019
- Review
- 272 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002338 (2001). 9 ancestors in all, the oldest K991920 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK002338 Liquiderm Liquid Adhesive BandageClosure Medical Corp. · 2001
- 5 generations backK031321 Liquishield Liquid Bandage, Model LSB 0001Medlogic Global Limited · 2004
- 4 generations backK050757 Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive…Chemence Medical, Inc. · 2006
- 3 generations backK063202 Proderma Liquid BandageProcurement Technology Systems, LLC · 2007
- 2 generations backK083913 Chesson Labs Liquid BandageChesson Laboratory Associates, Inc. · 2009
- 1 generation backK131384 Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage…Kericure, Inc. · 2014
- This deviceK182733 Rochal Bioshield Silicone FilmRochal Industries, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002338 | Liquiderm Liquid Adhesive Bandage | Closure Medical Corp. | 2001 | — |
| −5 | K031321 | Liquishield Liquid Bandage, Model LSB 0001 | Medlogic Global Limited | 2004 | — |
| −4 | K050757 | Flex-Aid Liquid Gel Bandage and Dermaflex Gel Tissue Adhesive Professional… | Chemence Medical, Inc. | 2006 | — |
| −3 | K063202 | Proderma Liquid Bandage | Procurement Technology Systems, LLC | 2007 | — |
| −2 | K083913 | Chesson Labs Liquid Bandage | Chesson Laboratory Associates, Inc. | 2009 | — |
| −1 | K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage | Kericure, Inc. | 2014 | — |
| 0 (this device) | K182733 | Rochal Bioshield Silicone Film | Rochal Industries, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageSummary page 4…Bandage, Liquid 6. Device Class and Regulation Number Class I, 21 CFR 880.5090 7. Product Code KMF 8. Predicate and Reference Devices: K131384 KeriCureTM Advanced Liquid Bandage, KeriCure Inc. (predicate device) K955103 No Sting Barrier Film, 3M Medical Product Grou… | 2014 |
| † | K955103 | 3M NO Sting Barrier Film | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K131384.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Rx: Bioshield Silicone Film is intended to cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
OTC: Bioshield Silicone Film is intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182733 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182733: Rochal Bioshield Silicone Film.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182733
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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