510(k) · Cleared
ClearedHemamyst Surgical Applicator System, Model H-AS01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemacure Corp. · FMF Syringe, Piston
Cleared on Aug 6, 2004 as substantially equivalent to K994023 (Haemacure Corp., 2000) and 1 other predicate after a 60-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Aug 6, 2004
- Review
- 60 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K872565 (1987). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK872565 Duoflo DispenserHemaedics, Inc. · 1987
- 3 generations backK964833 Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997
- 2 generations backK973510 Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997
- 1 generation backK981089 Tissomat and Spray SetBaxter Healthcare Corp · 2000
- This deviceK041504 Hemamyst Surgical Applicator System, Model H-AS01Haemacure Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K872565 | Duoflo Dispenser | Hemaedics, Inc. | 1987 | — |
| −3 | K964833 | Rmi Dual Fluid Irrigating Syringe | Research Medical, Inc. | 1997 | — |
| −2 | K973510 | Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML) | Immuno-U.S., Inc. | 1997 | — |
| −1 | K981089 | Tissomat and Spray Set | Baxter Healthcare Corp | 2000 | — |
| 0 (this device) | K041504 | Hemamyst Surgical Applicator System, Model H-AS01 | Haemacure Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K994023 | Haemacure Hemamyst Surgical Applicator System H-AS01Summary page 1…emaMyst Surgical Applicator System Common/Usual/Classification Name: Syringe, Piston Predicate Device(s): Haemacure HemaMyst Surgical Applicator System 510(k) No. K994023 Haemacure Corporation Tissomat and Spray Set 510(k) No. K981089 Baxter Healthcare Corporation Device Description:… | 2000 |
| * | K981089 | Tissomat and Spray SetSummary page 1…Syringe, Piston Predicate Device(s): Haemacure HemaMyst Surgical Applicator System 510(k) No. K994023 Haemacure Corporation Tissomat and Spray Set 510(k) No. K981089 Baxter Healthcare Corporation Device Description:… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K994023.
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 HemaMyst Surgical Applicator System is indicated for the simultaneous application of the two components of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041504 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041504: Hemamyst Surgical Applicator System, Model H-AS01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041504
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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