510(k) · Cleared
ClearedVitapatch Pin Protection Device for Percutaneous
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitaphore Corp. · KGX Tape And Bandage, Adhesive
Cleared on Jun 6, 1991 after a 603-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.
- Decided
- Jun 6, 1991
- Review
- 603 days
- Class
- Class I
- Product code
- KGX
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 1 citing it directly.
- This deviceK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- Descendant · cites it directly · 31 of its ownK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- Descendant · 2 generations on · 16 of its ownK063458 3M Tegaderm CHG Dressing3M Company · 2007 · Recalled
- Descendant · 2 generations on · 9 of its ownK080779 Irrisept Wound Cleansing SystemIrrimax Corporation · 2009 · Recalled
- Descendant · 3 generations on · 7 of its ownK202222 Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 2020
- Descendant · 3 generations on · 7 of its ownK080620 Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K003229Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001 · cites it directly31descendants
- K0634583M Tegaderm CHG Dressing3M Company · 2007 · 2 generations on16descendants
- K080779Irrisept Wound Cleansing SystemIrrimax Corporation · 2009 · 2 generations on9descendants
- K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 2020 · 3 generations on7descendants
- K080620Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| +1 | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| +2 | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | 1 |
| +2 | K080779 | Irrisept Wound Cleansing System | Irrimax Corporation | 2009 | 2 |
| +3 | K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | 2020 | — |
| +3 | K080620 | Modification to 3M Tegaderm CHG Dressing | 3M Company-3M Health Care | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K003229 | Biopatch Antimicrobial Dressing | 2001 | 31 |
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, K003229 (Integra Lifesciences Corp., 2001) has gone furthest, with 31 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/K895920 · printed Nov 5, 2026
Cite this page
510(k) Report. “K895920: Vitapatch Pin Protection Device for Percutaneous.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K895920
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026