510(k) · Cleared
ClearedIV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covalontechnologies, Inc. · FRO Dressing, Wound, Drug
Cleared on May 4, 2012 as substantially equivalent to K080620 (3M Company-3M Health Care, 2008) and 2 other predicates after a 246-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- May 4, 2012
- Review
- 246 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K895920 (1991). 10 ancestors in all, the oldest K895207 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- 3 generations backK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- 2 generations backK063458 3M Tegaderm CHG Dressing3M Company · 2007 · Recalled
- 1 generation backK080620 Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · Recalled
- This deviceK112549 IV Clear Antimicrobial Clear Silicone Adhesive Dressing with…Covalontechnologies, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| −3 | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| −2 | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | 1 |
| −1 | K080620 | Modification to 3M Tegaderm CHG Dressing | 3M Company-3M Health Care | 2008 | 1 |
| 0 (this device) | K112549 | IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and… | Covalontechnologies, Inc. | 2012 | — |
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? (4)
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 |
|---|---|---|---|
| * | K080620 | Modification to 3M Tegaderm CHG DressingSummary page 1…ces Manufacturer Device 510(k)j number 3M Health Care 3MTM Tegaderm M CHO Dressing K080620 3M Health Care 3MTM TegaderM TM Transparent Dressing K973036 Maersk Medical, Ltd. Arglaes" Film Antimic… | 2008 |
| * | K973036 | 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery)…Summary page 1…(k)j number 3M Health Care 3MTM Tegaderm M CHO Dressing K080620 3M Health Care 3MTM TegaderM TM Transparent Dressing K973036 Maersk Medical, Ltd. Arglaes" Film Antimicrobial Barrier Dressing K990810 Molnlycke Health Care Mepitac® Soft Silicon… | 1997 |
| * | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingSummary page 1…K080620 3M Health Care 3MTM TegaderM TM Transparent Dressing K973036 Maersk Medical, Ltd. Arglaes" Film Antimicrobial Barrier Dressing K990810 Molnlycke Health Care Mepitac® Soft Silicone Tape Class I 4. Indications for use IV Clear® is intende… | 1999 |
| * | — | Mepitac Soft Silicone Tape Named without a submission number |
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 21 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 3 other devices also cite its predicate K080620.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
IV Clear® is intended to cover and protect insertion sites, and secure devices to skin. Common applications include IV catheters, central venous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices. IV Clear® inhibits microbial growth within the dressing and prevents external contamination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112549: IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112549
Report an extraction error
Are you the manufacturer?
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