510(k) · Cleared

Cleared

Bitx Probes

K994336510(k) TraditionalCleared Feb 8, 200047-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

Everest Medical Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 8, 2000 as substantially equivalent to K904993 (Everest Medical Corp., 1991) and 1 other predicate after a 47-day review. Its family tree reaches back 1 generation to 1991.

Decided: Feb 8, 2000
Review: 47 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K904993 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
This deviceK994336 Bitx ProbesEverest Medical Corp. · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904993	Laparoscopic Electrosurgical Device	Everest Medical Corp.	1991	—
0 (this device)	K994336	Bitx Probes	Everest Medical Corp.	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K994336, 1991–2000Source: 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
*	K904993	Laparoscopic Electrosurgical Device Summary page 1 …edicate devices. The BiTx devices are similar in construction and in component materials as compared to laparoscopic devices (Ref. BILAP Probes submitted in 510(k) no’s. K904993 and K945975). The devices are tubular instruments, either 3mm or Smm in diameter, with shaft lengths of 12-15cm. The intended use…	Everest Medical Corp.	1991	—
*	K945975	Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps Summary page 1 …ces. The BiTx devices are similar in construction and in component materials as compared to laparoscopic devices (Ref. BILAP Probes submitted in 510(k) no’s. K904993 and K945975). The devices are tubular instruments, either 3mm or Smm in diameter, with shaft lengths of 12-15cm. The intended use of the devi…	Everest Medical Corp.	1994	—

Also cleared against K904993: 11 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?

None of the 2 ancestors has a recall.
11 other devices also cite its predicate K904993.

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.

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?

Electrosurgical Coagulation of soft tissue during ENT procedures.

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/K994336 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994336: Bitx Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994336

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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