510(k) · Cleared
ClearedSealouette Fibrin Sealant Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosurgical Corp. · FMF Syringe, Piston
Cleared on Oct 8, 1999 as substantially equivalent to K964597 (Biosurgical Corp., 1997) after an 86-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Oct 8, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964597 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964597 Biosurgical, Corp. Multi Chamber Suction SyringeBiosurgical Corp. · 1997
- This deviceK992351 Sealouette Fibrin Sealant ApplicatorBiosurgical Corp. · 1999
- Descendant · cites it directly · 1 of its ownK020666 Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · Recalled
- Descendant · cites it directly · 1 of its ownK014088 DuploreachBaxter Healthcare Corp · 2002
- Descendant · 2 generations on · 0 of its ownK071126 Cryoseal FS Applicator SystemThermogenesis Corp. · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964597 | Biosurgical, Corp. Multi Chamber Suction Syringe | Biosurgical Corp. | 1997 | — |
| 0 (this device) | K992351 | Sealouette Fibrin Sealant Applicator | Biosurgical Corp. | 1999 | — |
| +1 | K020666 | Duploject Easy-Prep System 1ML, 2ML, 5ML | Baxter Healthcare Corp | 2002 | 1 |
| +1 | K014088 | Duploreach | Baxter Healthcare Corp | 2002 | — |
| +2 | K071126 | Cryoseal FS Applicator System | Thermogenesis Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2007 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 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 |
|---|---|---|---|
| * | K964597 | Biosurgical, Corp. Multi Chamber Suction SyringeSummary page 2…s and materials. The Sealouette™ suction system design is precisely the same as that of the predicate device, BioSurgical’s Multi Chamber Suction Syringe cleared under #K964597. Both the BioSurgical Sealouette™ and the Immuno-U.S. Duploject® are intended for use in the delivery of fibrin sealant. Both de… | 1997 |
| * | — | Immuno-U.S. Duploject® Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
For the mixing, and one-to-one (1:1) delivery, of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of debris, excess tissue or foreign particles in the wound.
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/K992351 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992351: Sealouette Fibrin Sealant Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992351
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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