510(k) · Cleared
ClearedTissomat and Spray Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FMF Syringe, Piston
Cleared on Jul 5, 2000 as substantially equivalent to K973510 (Immuno-U.S., Inc., 1997) after an 833-day review. Its family tree reaches back 3 generations to 1987. 3 later devices descend from it.
- Decided
- Jul 5, 2000
- Review
- 833 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K872565 (1987). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK872565 Duoflo DispenserHemaedics, Inc. · 1987
- 2 generations backK964833 Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997
- 1 generation backK973510 Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997
- This deviceK981089 Tissomat and Spray SetBaxter Healthcare Corp · 2000
- Descendant · cites it directly · 0 of its ownK050495 Easyspray and Spray Set for Tisseel (Fiber Sealant)Baxter Healthcare Corp., Bioscience · 2005
- Descendant · cites it directly · 0 of its ownK041504 Hemamyst Surgical Applicator System, Model H-AS01Haemacure Corp. · 2004
- Descendant · cites it directly · 0 of its ownK030032 Crosseal Application DeviceOmrix Biopharmaceuticals, Inc. · 2003 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K050495Easyspray and Spray Set for Tisseel (Fiber Sealant)Baxter Healthcare Corp., Bioscience · 2005 · cites it directly0descendants
- K041504Hemamyst Surgical Applicator System, Model H-AS01Haemacure Corp. · 2004 · cites it directly0descendants
- K030032Crosseal Application DeviceOmrix Biopharmaceuticals, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872565 | Duoflo Dispenser | Hemaedics, Inc. | 1987 | — |
| −2 | K964833 | Rmi Dual Fluid Irrigating Syringe | Research Medical, Inc. | 1997 | — |
| −1 | K973510 | Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML) | Immuno-U.S., Inc. | 1997 | — |
| 0 (this device) | K981089 | Tissomat and Spray Set | Baxter Healthcare Corp | 2000 | — |
| +1 | K050495 | Easyspray and Spray Set for Tisseel (Fiber Sealant) | Baxter Healthcare Corp., Bioscience | 2005 | — |
| +1 | K041504 | Hemamyst Surgical Applicator System, Model H-AS01 | Haemacure Corp. | 2004 | — |
| +1 | K030032 | Crosseal Application Device | Omrix Biopharmaceuticals, Inc. | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K973510 | Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Summary page 1…was Prepared 03-May-2000 Name(s) of the Device" Tissomat® and Spray Set Identification of Predicate Device(s) Duploject® Baxter Healthcare Corporation, Hyland Immuno K973510 Description of the Device The Spray Set is a sterile, pyrogen-free, single-use device indicated for use in the simuttaneous app… | 1997 |
What descends from it? (3)
3 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K050495 (Baxter Healthcare Corp., Bioscience, 2005) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K973510.
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?
The Tissomat® and Spray Set are intended for use in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces. The Spray Set is attached to the Duploject® two-syringe holder and is equipped with a Spray Head and a connection tube which connects the Spray Head to the Tissomat® device, a propellant gas control device.
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/K981089 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981089: Tissomat and Spray Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981089
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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