510(k) · Cleared

Cleared

Haemacure Hemamyst Surgical Applicator System H-AS01

K994023510(k) TraditionalCleared Apr 25, 2000151-day reviewClass II21 CFR 880.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Apr 25, 2000 as substantially equivalent to K964597 (Biosurgical Corp., 1997) after a 151-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.

Decided: Apr 25, 2000
Review: 151 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.

By dateBy generation

Root · 1 generation backK964597 Biosurgical, Corp. Multi Chamber Suction SyringeBiosurgical Corp. · 1997
This deviceK994023 Haemacure Hemamyst Surgical Applicator System H-AS01Haemacure Corp. · 2000
Descendant · cites it directly · 1 of its ownK050998 Confluent Surgical Micromyst Applicator and Air Pump, Models…Confluent Surgical,Inc · 2005
Descendant · 2 generations on · 0 of its ownK070814 Modification to Confluent Surgical Micromyst Applicator and Air PumpConfluent Surgical,Inc · 2007
Descendant · cites it directly · 0 of its ownK041504 Hemamyst Surgical Applicator System, Model H-AS01Haemacure Corp. · 2004

Most influential descendants

Showing 3 of 3 · See all

K050998Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063Confluent Surgical,Inc · 2005 · cites it directly1descendant
K070814Modification to Confluent Surgical Micromyst Applicator and Air PumpConfluent Surgical,Inc · 2007 · 2 generations on0descendants
K041504Hemamyst Surgical Applicator System, Model H-AS01Haemacure Corp. · 2004 · cites it directly0descendants

View 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)	K994023	Haemacure Hemamyst Surgical Applicator System H-AS01	Haemacure Corp.	2000	—
+1	K050998	Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063	Confluent Surgical,Inc	2005	—
+2	K070814	Modification to Confluent Surgical Micromyst Applicator and Air Pump	Confluent Surgical,Inc	2007	—
+1	K041504	Hemamyst Surgical Applicator System, Model H-AS01	Haemacure Corp.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2007	1	0

FIG. 1 — Lineage of K994023, 1997–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K964597	Biosurgical, Corp. Multi Chamber Suction Syringe Summary page 1 …valence of the Haemacure HemaMyst Surgical Applicator System is made to the following predicate device: Biosurgical, Corp. Multi Chamber Suction Syringe; 510(k) Number K964597. (Also marketed as the Biosurgical Sealouette System) Marketed by: BioSurgical Corporation 5990 Stoneridge Drive Suite 112 Pleas…	Biosurgical Corp.	1997	—

Also cleared against K964597: 1 other device →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050998	Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063	Confluent Surgical,Inc	2005	1
K041504	Hemamyst Surgical Applicator System, Model H-AS01	Haemacure Corp.	2004	0

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?

Its one ancestor has no recall.
Of its descendants, K050998 (Confluent Surgical,Inc, 2005) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K964597.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007high 239 (2026) · low 74 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMF

19in 2023

2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007high 5,874 (2021) · low 186 (2011)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?

Haemacure HemaMyst Surgical Applicator System is indicated for the

application of two non-homogeneous fluids or solutions to the treatment site.

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/K994023 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994023: Haemacure Hemamyst Surgical Applicator System 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/K994023

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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