510(k) · Cleared

Recalled · 2010

Model P8400 Hemostatix Thermal Scalpel System

K091107510(k) TraditionalCleared May 1, 200915-day reviewClass II21 CFR 878.4400Recalls 2

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

Hemostatix Medical Technologies, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 1, 2009 as substantially equivalent to K033089 (Gyrus Ent LLC, 2004) after a 15-day review. Its family tree reaches back 1 generation to 2004. 8 later devices descend from it. It has been recalled 2 times.

Decided: May 1, 2009
Review: 15 days
Class: Class II
Product code: GEI
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K033089 (2004). 8 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK033089 Hemostatix, Model 2400Z Thermal Scalpel SystemGyrus Ent LLC · 2004 · Recalled
This deviceK091107 Model P8400 Hemostatix Thermal Scalpel SystemHemostatix Medical Technologies, LLC · 2009
Descendant · cites it directly · 5 of its ownK110439 Domain Surgical SystemDomain Surgical, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK121881 Domain Surgical SystemDomain Surgical, Inc. · 2012
Descendant · 3 generations on · 3 of its ownK130606 Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014
Descendant · 4 generations on · 1 of its ownK141484 Open FmsealerDomain Surgical, Inc. · 2014 · Recalled
Descendant · cites it directly · 0 of its ownK233185 MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel SystemC2dx, Inc. · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2011high 3 (2014) · low 0 (2013)2026

Most influential descendants

Showing 5 of 8 · See all

K110439Domain Surgical SystemDomain Surgical, Inc. · 2011 · cites it directly5descendants
K121881Domain Surgical SystemDomain Surgical, Inc. · 2012 · 2 generations on4descendants
K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014 · 3 generations on3descendants
K141484Open FmsealerDomain Surgical, Inc. · 2014 · 4 generations on1descendant
K233185MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel SystemC2dx, Inc. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033089	Hemostatix, Model 2400Z Thermal Scalpel System	Gyrus Ent LLC	2004	2
0 (this device)	K091107	Model P8400 Hemostatix Thermal Scalpel System	Hemostatix Medical Technologies, LLC	2009	—
+1	K110439	Domain Surgical System	Domain Surgical, Inc.	2011	—
+2	K121881	Domain Surgical System	Domain Surgical, Inc.	2012	—
+3	K130606	Fmwand Ferromagnetic Surgical System	Domain Surgical, Inc.	2014	—
+4	K141484	Open Fmsealer	Domain Surgical, Inc.	2014	1
+1	K233185	MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System	C2dx, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2014	3	0
2015	1	0
2018	1	0
2023	1	0

FIG. 1 — Lineage of K091107, 2004–2023Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K033089	Hemostatix, Model 2400Z Thermal Scalpel System Summary page 1 …temperature ranges (700 C to 3000 C), and, utilizes the same blades as the predicate device, the H-emostatix Model 2400Z Thermal Scalpel System cleared via 5 10(k) No.: K033089. The Model P8400 Hemostatix Thermal Scalpel System differs from the predicate device in that the Model P8400 Hemostatix Thermal S…	Gyrus Ent LLC	2004	2

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K110439	Domain Surgical System	Domain Surgical, Inc.	2011	5
K233185	MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System	C2dx, Inc.	2023	0
K183009	Hemostatix Model P8400 Disposable Handle, Hemostatix Model P8400 Disposable Blades	Hemostatix Medical Technologies, LLC	2018	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 27, 2010	Not classified	Z-2595-2010	Other	Lack of sterility assurance
Jul 27, 2010	Not classified	Z-2596-2010	Other	Lack of sterility assurance

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K110439 (Domain Surgical, Inc., 2011) has gone furthest, with 5 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The Model P8400 Hemostatix Thermal Scalpel System is a surgical instrument designed

to retain the precise, clean cutting characteristics of a traditional steel scalpel and to

minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal

tissue damage and virtually no muscle stimulation, using heat thermally conducted to the

tissue from an elevated-temperature blade.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091107 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091107: Model P8400 Hemostatix Thermal Scalpel System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091107

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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