510(k) · Cleared

Recalled · Class II · 2019

Cautery Tip Cleaner, Model 30500

K053433510(k) TraditionalCleared Jan 19, 200641-day reviewClass II21 CFR 878.4400Recalls 3

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

Xodus Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jan 19, 2006 as substantially equivalent to K030339 (Aspen Surgical Products, Inc., 2003) after a 41-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it. It has been recalled 3 times.

Decided: Jan 19, 2006
Review: 41 days
Class: Class II
Product code: GEI
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K030339 (2003). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK030339 Cautery Tip Cleaner, Model-TC-100Aspen Surgical Products, Inc. · 2003
This deviceK053433 Cautery Tip Cleaner, Model 30500Xodus Medical, Inc. · 2006
Descendant · cites it directly · 1 of its ownK151222 Cautery Tip CleanerKey Surgical, Inc. · 2015
Descendant · 2 generations on · 0 of its ownK241022 Sterile single use tip cleaner (WK800-S10 , WK800-S20)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2024

Most influential descendants

Showing 2 of 2 · See all

K151222Cautery Tip CleanerKey Surgical, Inc. · 2015 · cites it directly1descendant
K241022Sterile single use tip cleaner (WK800-S10 , WK800-S20)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K030339	Cautery Tip Cleaner, Model-TC-100	Aspen Surgical Products, Inc.	2003	—
0 (this device)	K053433	Cautery Tip Cleaner, Model 30500	Xodus Medical, Inc.	2006	—
+1	K151222	Cautery Tip Cleaner	Key Surgical, Inc.	2015	—
+2	K241022	Sterile single use tip cleaner (WK800-S10 , WK800-S20)	Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2024	1	0

FIG. 1 — Lineage of K053433, 2003–2024Source: 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
*	K030339	Cautery Tip Cleaner, Model-TC-100 Summary page 1 …ber: 21 CFR 878.4400 Product Code: GEL Regulatory Class: TI Predicate Device Device Name: Electro-Cautery Tip Cleaner Common Name: Cautery Tip Cleaner 510 (k) Number: K030339 510 (k) Owner: Aspen Surgical Products Classification Name: Electrosurgical, Cutting & Coagulation Device & Accessories Regulatio…	Aspen Surgical Products, Inc.	2003	—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K151222	Cautery Tip Cleaner	Key Surgical, Inc.	2015	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 19, 2019	Class II	Z-0150-2020	Packaging	The sterile barrier of some devices may have been affected
Sep 19, 2019	Class II	Z-0151-2020	Packaging	The sterile barrier of some devices may have been affected
Sep 19, 2019	Class II	Z-0149-2020	Packaging	The sterile barrier of some devices may have been affected

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K151222 (Key Surgical, Inc., 2015) has gone furthest, with 1 descendant 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.

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 disposable Cautcry Tip Cleaner is a single use sterile product. Its intended use is as an electrosurgical accessory to clean uncoated cautery blades that are part of an electrosurgical pencil. The cautery blade is "scratched" on the cautery tip cleaner to remove eschar build-up during surgical procedures to allow the cautery blade to function effectively throughout the procedure. The product is usually placed somewhere on the sterile field, typically on the mayo stand. This product does not come in contact with the patient.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053433 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053433: Cautery Tip Cleaner, Model 30500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053433

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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