510(k) · Cleared
ClearedChloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entrotech Life Sciences, Inc. · FRO Dressing, Wound, Drug
Cleared on Nov 7, 2014 as substantially equivalent to K121819 (Covalontechnologies, Inc., 2012) and 1 other predicate after a 266-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Nov 7, 2014
- Review
- 266 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K895920 (1991). 11 ancestors in all, the oldest K895207 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- 4 generations backK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- 3 generations backK063458 3M Tegaderm CHG Dressing3M Company · 2007 · Recalled
- 2 generations backK080620 Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · Recalled
- 1 generation backK121819 Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with…Covalontechnologies, Inc. · 2012
- This deviceK140389 Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2…Entrotech Life Sciences, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| −4 | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| −3 | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | 1 |
| −2 | K080620 | Modification to 3M Tegaderm CHG Dressing | 3M Company-3M Health Care | 2008 | 1 |
| −1 | K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine… | Covalontechnologies, Inc. | 2012 | — |
| 0 (this device) | K140389 | Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4… | Entrotech Life Sciences, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1997 | 3 | 0 |
| 1999 | 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 FRO? 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 |
|---|---|---|---|
| * | K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverSummary page 5…10(k) SUMMARY (CONT.) PREDICATE DEVICE(S) x Covalon SurgiClear™ Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver (“SurgiClear”) (K121819) x 3M™ Tegaderm™ Transparent Dressings (“Tegaderm”) (K973036) INDICATIONS FOR USE The entrotech life sciences inc. ChloraDe… | 2012 |
| * | K973036 | 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery)…Summary page 5…ar™ Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver (“SurgiClear”) (K121819) x 3M™ Tegaderm™ Transparent Dressings (“Tegaderm”) (K973036) INDICATIONS FOR USE The entrotech life sciences inc. ChloraDerm™ Antimicrobial Transparent Thin Film Dressings are intended to… | 1997 |
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 23 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K121819.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The entrotech life sciences inc. ChloraDerm™ Antimicrobial Transparent Thin Film Dressings are intended to cover and
protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures and wires.
ChloraDerm™ may also be used to cover and secure primary dressings.
ChloraDerm™ inhibits microbial growth within the dressing and prevents external contamination.
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/K140389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140389: Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140389
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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