510(k) · Cleared

Cleared

Hemostatix Model P8400 Disposable Handle, Hemostatix Model P8400 Disposable Blades

K183009510(k) SpecialCleared Nov 26, 201826-day reviewClass II21 CFR 878.4400

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 Nov 26, 2018 as substantially equivalent to K091107 (Hemostatix Medical Technologies, LLC, 2009) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 2004.

Decided: Nov 26, 2018
Review: 26 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K033089 (2004). 3 ancestors in all, the oldest K002021 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK033089 Hemostatix, Model 2400Z Thermal Scalpel SystemGyrus Ent LLC · 2004 · Recalled
1 generation backK091107 Model P8400 Hemostatix Thermal Scalpel SystemHemostatix Medical Technologies, LLC · 2009 · Recalled
This deviceK183009 Hemostatix Model P8400 Disposable Handle, Hemostatix Model P8400…Hemostatix Medical Technologies, LLC · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K033089	Hemostatix, Model 2400Z Thermal Scalpel System	Gyrus Ent LLC	2004	2
−1	K091107	Model P8400 Hemostatix Thermal Scalpel System	Hemostatix Medical Technologies, LLC	2009	2
0 (this device)	K183009	Hemostatix Model P8400 Disposable Handle, Hemostatix Model P8400 Disposable…	Hemostatix Medical Technologies, LLC	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K183009, 2004–2018Source: 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? (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
*	K091107	Model P8400 Hemostatix Thermal Scalpel System Summary page 4 …or Usual Name: Thermal Scalpel Regulatory Class: II Product Code: GEI III. PREDICATE DEVICE a) Hemostatix Thermal Scalpel System Handles – Original 510(k) K091107, Hemostatix Thermal Scalpel System, May 1, 2009. b) Hemostatix Thermal Scalpel System Blades – Original 510(k) K00…	Hemostatix Medical Technologies, LLC	2009	2
*	K002021	Hemostatix Thermal Scalpel System - #12 Blade Summary page 4 …el System Handles – Original 510(k) K091107, Hemostatix Thermal Scalpel System, May 1, 2009. b) Hemostatix Thermal Scalpel System Blades – Original 510(k) K002021, Hemostatix Thermal Scalpel System, August 24, 2000. These predicate devices have not been subject to a design-relat…	Gyrus Ent LLC	2000	—

Also cleared against K091107: 2 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)

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 14 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
2 of the 3 ancestors have a recall of any class.
2 other devices also cite its predicate K091107.

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. 2018, 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 Hemostatix Thermal Scalpel System Handles and Blades are a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional stainless 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K183009 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183009: Hemostatix Model P8400 Disposable Handle, Hemostatix Model P8400 Disposable Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183009

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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