510(k) · Cleared

Cleared

Neothermia EN-Bloc Biopsy System

K050737510(k) SpecialCleared Mar 31, 200510-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

Neothermia Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 31, 2005 after a 10-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Mar 31, 2005
Review: 10 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK050737 Neothermia EN-Bloc Biopsy SystemNeothermia Corporation · 2005
Descendant · cites it directly · 0 of its ownK102756 Surecore Biopsy DeviceChest Innovations, Inc. · 2011
Descendant · cites it directly · 0 of its ownK052246 Modification to EN-Bloc Biopsy SystemNeothermia Corporation · 2005

Most influential descendants

Showing 2 of 2 · See all

K102756Surecore Biopsy DeviceChest Innovations, Inc. · 2011 · cites it directly0descendants
K052246Modification to EN-Bloc Biopsy SystemNeothermia Corporation · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K050737	Neothermia EN-Bloc Biopsy System	Neothermia Corporation	2005	—
+1	K102756	Surecore Biopsy Device	Chest Innovations, Inc.	2011	—
+1	K052246	Modification to EN-Bloc Biopsy System	Neothermia Corporation	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2011	1	0

FIG. 1 — Lineage of K050737, 2005–2011Source: 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? (4)

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	Recalls
*	—	Neothermia's 10mm en-bloc probe Named without a submission number	—
*	—	Neothermia's 12mm en-bloc probe Named without a submission number	—
*	—	Neothermia's 15mm en-bloc probe Named without a submission number	—
*	—	Neothermia's 20mm en-bloc probe Named without a submission number	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K102756	Surecore Biopsy Device	Chest Innovations, Inc.	2011	0
K052246	Modification to EN-Bloc Biopsy System	Neothermia Corporation	2005	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?

Of its descendants, K102756 (Chest Innovations, Inc., 2011) has gone furthest, with 0 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.

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 en-bloc Biopsy System is intented for diagnostic :sampling of breast tissue during a breast biopsy procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050737 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050737: Neothermia EN-Bloc Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050737

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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