510(k) · Cleared

Cleared

Tti Thermomed Model 1.8 Instrument

K021117510(k) SpecialCleared May 2, 200224-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

Thermosurgery Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 2, 2002 as substantially equivalent to K894166 (Rdm Intl., Inc., 1989) after a 24-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.

Decided: May 2, 2002
Review: 24 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K894166 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK894166 Thermosurgery TMRdm Intl., Inc. · 1989
This deviceK021117 Tti Thermomed Model 1.8 InstrumentThermosurgery Technologies, Inc. · 2002
Descendant · cites it directly · 0 of its ownK063748 Thermomed 1.8Thermosurgery Technologies, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K063748Thermomed 1.8Thermosurgery Technologies, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894166	Thermosurgery TM	Rdm Intl., Inc.	1989	—
0 (this device)	K021117	Tti Thermomed Model 1.8 Instrument	Thermosurgery Technologies, Inc.	2002	—
+1	K063748	Thermomed 1.8	Thermosurgery Technologies, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K021117, 1989–2007Source: 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
*	K894166	Thermosurgery TM Summary page 1 …TTI ThermoMed™ Model 1.8 Instrument Localized current field radio frequency instrument Device, Electrosurgical, Cutting and Coagulation Accessories, Class GEI/878.4400 K894166 — RDM Thermosurgery™ Localized Current Field RF Instrument GEI / 878.4400/Classl\| The TTI ThermoMed device delivers controlled l…	Rdm Intl., Inc.	1989	—

Also cleared against K894166: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K063748	Thermomed 1.8	Thermosurgery Technologies, Inc.	2007	0

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?

Its one ancestor has no recall.
Of its descendants, K063748 (Thermosurgery Technologies, Inc., 2007) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K894166.

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 TTI ThermoMed™ Model 1.8 Instrument provides the

therapeutic modality to treat the following benign diseases and

conditions:

Warts

Molluscum Contagiosum

Angioma

Fibroma

Seborrheic Keratoses

Acrochordon

Syringoma

Hydrocystoma

9. Clavus

10. Actinic Keratoses

11. Keloids

12. Epidermoid Cysts

13. Cystic Acne

14. Cutaneous Leishmaniasis

15. Atypical Mycobacteria

16. Dermatophytosis

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/K021117 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021117: Tti Thermomed Model 1.8 Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021117

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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