510(k) · Cleared

Recalled · 2004

Crosseal Application Device

K030032510(k) TraditionalCleared Mar 21, 200377-day reviewClass II21 CFR 880.5570Recalls 1

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

Omrix Biopharmaceuticals, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Mar 21, 2003 as substantially equivalent to K973510 (Immuno-U.S., Inc., 1997) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 1987. It has been recalled once.

Decided: Mar 21, 2003
Review: 77 days
Class: Class II
Product code: FMI
Recalls: 1
Predicates: 2

Its longest line of descent runs back 4 generations to K872565 (1987). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

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 deviceK030032 Crosseal Application DeviceOmrix Biopharmaceuticals, Inc. · 2003

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)	K030032	Crosseal Application Device	Omrix Biopharmaceuticals, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0

FIG. 1 — Lineage of K030032, 1987–2003Source: 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 FMI? 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 FMI device

#1 K252886 Pen Needlescore 14.5 · 4 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? (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	Applicant	Decided	Recalls
*	K973510	Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML) Summary page 1 …was Prepared: March 2003 Name of Device: CrossealTMApplication Device Identification of Predicate Devices: Duploject‘Y Baxter Healthcare Corporation, Hyland b u n 0 K973510 Mixject@Dispensing Pin with Detachable Vial Holder Medimop Medical Projects, Ltd. (Israel) K963583 Tissornat@and Spray Set Baxt…	Immuno-U.S., Inc.	1997	—
*	K981089	Tissomat and Spray Set Summary page 1 …xject@Dispensing Pin with Detachable Vial Holder Medimop Medical Projects, Ltd. (Israel) K963583 Tissornat@and Spray Set Baxter Healthcare Corporation, Hyland h m u n o K981089 Description of Device: The CrossealTY Application Device is a sterile, single-use, disposable two-syringe device used for the…	Baxter Healthcare Corp	2000	—

Also cleared against K973510: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 6, 2004	Not classified	Z-1497-04	Other	5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port .

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
1 of the 5 ancestors has a recall of any class.
3 other devices also cite its predicate K973510.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, 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	15	71	2	208
2008	10	85	4	177
2009	7	177	3	263
2010	15	119	79	249
2011	12	113	5	240
2012	17	107	1	215
2013	11	87	1	255
2014	14	155	3	287
2015	10	89	1	567
2016	20	217	0	941
2017	9	253	16	1,547
2018	20	176	0	2,398
2019	12	186	5	4,896
2020	11	263	3	4,245
2021	18	143	7	4,532
2022	23	189	0	4,885
2023	18	112	2	4,986
2024	3	90	1	4,053
2025	11	141	0	2,424
2026	12	119	1 (1)	—

What is it indicated for?

The CrossealTMApplication Device is intended for the simultaneous topical application of the two biological components of CrossealTMFibrin Sealant via dripping (no air pressure) or via spraying (with air pressure utilizing the pressure regulator unit) onto the surface of the liver in patients undergoing liver surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030032 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030032: Crosseal Application Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030032

Report an extraction error

Are you the manufacturer?

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