510(k) · Cleared
ClearedOpsite I.V. 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew United, Inc. · KGX Tape And Bandage, Adhesive
Cleared on Sep 28, 1989 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Sep 28, 1989
- Review
- 27 days
- Class
- Class I
- Product code
- KGX
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK895353 Opsite I.V. 3000Smith & Nephew United, Inc. · 1989
- Descendant · cites it directly · 7 of its ownK080620 Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · Recalled
- Descendant · 2 generations on · 3 of its ownK121819 Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with…Covalontechnologies, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK153410 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK163529 ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op…Avery Dennison Corporation · 2017
- Descendant · 4 generations on · 0 of its ownK251866 Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K080620Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · cites it directly7descendants
- K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc. · 2012 · 2 generations on3descendants
- K1534103M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017 · 2 generations on1descendant
- K163529ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG…Avery Dennison Corporation · 2017 · 3 generations on1descendant
- K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895353 | Opsite I.V. 3000 | Smith & Nephew United, Inc. | 1989 | — |
| +1 | K080620 | Modification to 3M Tegaderm CHG Dressing | 3M Company-3M Health Care | 2008 | 1 |
| +2 | K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine… | Covalontechnologies, Inc. | 2012 | — |
| +2 | K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 3M Company | 2017 | 1 |
| +3 | K163529 | ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing… | Avery Dennison Corporation | 2017 | — |
| +4 | K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2025 | 1 | 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.
Planning a device in KGX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080620 | Modification to 3M Tegaderm CHG Dressing | 2008 | 7 |
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?
- Of its descendants, K080620 (3M Company-3M Health Care, 2008) has gone furthest, with 7 descendants of its own.
How does its category compare?
All KGX devicesKGX Tape And Bandage, Adhesive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGX
FDA has decided no KGX device since 2007.
Median 510(k) review, days · KGX
Too few KGX 510(k)s in any year since 2007 to give a median.
Recalls per year · KGX
8in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGX
317in 2025
MAUDE reports naming product code KGX, 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 | 0 | — | 0 | 37 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 0 | — | 0 | 37 |
| 2010 | 0 | — | 8 | 31 |
| 2011 | 0 | — | 4 | 39 |
| 2012 | 0 | — | 2 | 59 |
| 2013 | 0 | — | 0 | 88 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 3 | 200 |
| 2016 | 0 | — | 0 | 158 |
| 2017 | 0 | — | 0 | 206 |
| 2018 | 0 | — | 0 | 213 |
| 2019 | 0 | — | 1 | 488 |
| 2020 | 0 | — | 0 | 1,290 |
| 2021 | 0 | — | 0 | 562 |
| 2022 | 0 | — | 0 | 253 |
| 2023 | 0 | — | 0 | 192 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 0 | — | 8 | 317 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K895353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K895353: Opsite I.V. 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895353
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026