510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

EN Bloc Biopsy System

K003190510(k) TraditionalCleared Jun 11, 2001243-day reviewClass II21 CFR 878.4400Recalls 11

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

Neothermia Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jun 11, 2001 after a 243-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 11 times.

Decided
Jun 11, 2001
Review
243 days
Class
Class II
Product code
GEI
Recalls
11
Predicates
0

9 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2002: 4 descendants cleared2003: 2 descendants cleared2007: 1 descendant cleared200020052010201520202025
  1. This deviceK003190 EN Bloc Biopsy SystemNeothermia Corp. · 2001
  2. Descendant · cites it directly · 5 of its ownK020047 Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK023601 Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2002 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK030049 Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2003 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK052506 Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 2005 · Recalled
  6. Descendant · cites it directly · 1 of its ownK020031 EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002…Neothermia Corp. · 2002

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2002: 42003: 22005: 22007: 1
2002high 4 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 9 · See all
  • K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 2002 · cites it directly5descendants
  • K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2002 · 2 generations on4descendants
  • K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2003 · 3 generations on3descendants
  • K052506Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 2005 · 3 generations on1descendant
  • K020031EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302Neothermia Corp. · 2002 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003190EN Bloc Biopsy SystemNeothermia Corp.2001—
+1K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc.20021
+2K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc.20021
+3K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc.20031
+3K052506Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc.20051
+1K020031EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006…Neothermia Corp.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200240
200320
200520
200710
FIG. 1 — Lineage of K003190, 2001–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc.20025
K020031EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302Neothermia Corp.20021
K052246Modification to EN-Bloc Biopsy SystemNeothermia Corporation20050
K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc.20020

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 28, 2016Class IIZ-1132-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier
Dec 28, 2016Class IIZ-1130-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier
Dec 28, 2016Class IIZ-1134-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier
Dec 28, 2016Class IIZ-1126-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier
Dec 28, 2016Class IIZ-1133-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier
Dec 28, 2016Class IIZ-1129-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier
Dec 28, 2016Class IIZ-1136-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier
Dec 28, 2016Class IIZ-1127-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier
Dec 28, 2016Class IIZ-1131-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier
Dec 28, 2016Class IIZ-1135-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier
Dec 28, 2016Class IIZ-1128-2017Package design/selectionProduct sterility compromised due to breach of sterile barrier

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K020047 (Rubicor Medical, Inc., 2002) has gone furthest, with 5 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

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
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

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

More from Neothermia Corp.

7 FDA decisions under this applicant name. See the company

  • K041347Modification to EN-Bloc Biopsy SystemNeothermia Corp. · 2004
  • K033427Modification to EN-Bloc Biopsy SystemNeothermia Corp. · 2003
  • K023413Modification to Neothermia's EN-Bloc Biopsy SystemNeothermia Corp. · 2002
  • K022296Modification to EN-Bloc Biopsy SystemNeothermia Corp. · 2002
  • K021577Modification to EN-Bloc Biopsy SystemNeothermia Corp. · 2002

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https://510kreport.com/device/K003190 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003190: 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/K003190

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026