510(k) · Cleared
ClearedFloraseal, Model FS350D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adhezion Biomedical · NZP Sealant, Microbial
Cleared on Jul 20, 2009 after a 249-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jul 20, 2009
- Review
- 249 days
- Class
- Class II
- Product code
- NZP
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK083354 Floraseal, Model FS350DAdhezion Biomedical · 2009
- Descendant · cites it directly · 1 of its ownK170505 SecurePortIV Catheter Securement AdhesiveAdhezion Biomedical, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK223669 SecurePortIV Advanced Catheter Securement AdhesiveAdhezion Biomedical, LLC · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083354 | Floraseal, Model FS350D | Adhezion Biomedical | 2009 | — |
| +1 | K170505 | SecurePortIV Catheter Securement Adhesive | Adhezion Biomedical, LLC | 2017 | — |
| +2 | K223669 | SecurePortIV Advanced Catheter Securement Adhesive | Adhezion Biomedical, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 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 NZP? 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 NZP device
- #1 K223669 SecurePortIV Advanced Catheter Securement…score 5.8 · 2 generations · 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 |
|---|---|---|---|
| * | — | Integuseal Microbial Sealant Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170505 | SecurePortIV Catheter Securement Adhesive | 2017 | 1 |
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, K170505 (Adhezion Biomedical, LLC, 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NZP devicesNZP Sealant, Microbial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NZP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NZP
Too few NZP 510(k)s in any year since 2007 to give a median.
Recalls per year · NZP
No recall names NZP since 2007.
Adverse event reports per year · NZP
1in 2025
MAUDE reports naming product code NZP, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Flora SealTM Microbial Sealant is intended for use after topical operative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of the skin flora contamination throughout a surgical. procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083354: Floraseal, Model FS350D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083354
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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