510(k) Report

510(k) · Cleared

Cleared

Tumorlocalizer Mri

K962615510(k) TraditionalCleared Mar 19, 1998624-day reviewClass U

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

Ferguson Medical · MIG Strip, Test Isoniazid

Cleared on Mar 19, 1998 as substantially equivalent to K863848 (Manan Manufacturing Co., Inc., 1986) and 4 other predicates after a 624-day review. Its family tree reaches back 1 generation to 1986.

Decided
Mar 19, 1998
Review
624 days
Class
Class U
Product code
MIG
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K863090 (1986). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 3 other ancestors1986: 1 other ancestorK863090 · Percu Guide I (Loop Type) · E-Z-Em, Inc. · 19861985199019952000
Other ancestors, by generation 1 generation back: 4 other ancestors K863090 · Percu Guide I (Loop Type) · E-Z-Em, Inc. · 19860
  1. Root · 1 generation backK863090 Percu Guide I (Loop Type)E-Z-Em, Inc. · 1986
  2. This deviceK962615 Tumorlocalizer MriFerguson Medical · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K863090Percu Guide I (Loop Type)E-Z-Em, Inc.1986—
0 (this device)K962615Tumorlocalizer MriFerguson Medical1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199230
FIG. 1 — Lineage of K962615, 1986–1998Source: 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), 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 MIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K863848Manan Brest Tumor Localization Needle
Summary page 1
…ommon /usual name: Tumor localizer, lesion marker, and others. Proprietary name: TumorLocalizer MRI B. Substantial equivalence: Manan Breast Tumor Localization Needle (K863848), Simon Breast Lesion Localization Needle (K914941), MD Tech Kopan Target (K915417), E-Z-Em PercuGuide I (K863090), E-Z-Em PercuG…
Manan Manufacturing Co., Inc.1986—
*K914941Simon Breast Lesion Localization Needle
Summary page 1
…and others. Proprietary name: TumorLocalizer MRI B. Substantial equivalence: Manan Breast Tumor Localization Needle (K863848), Simon Breast Lesion Localization Needle (K914941), MD Tech Kopan Target (K915417), E-Z-Em PercuGuide I (K863090), E-Z-Em PercuGuide Lesion Marking device (K920816), and others.…
Manan Medical Products, Inc.1992—
*K915417Kopan's Target
Summary page 1
…umorLocalizer MRI B. Substantial equivalence: Manan Breast Tumor Localization Needle (K863848), Simon Breast Lesion Localization Needle (K914941), MD Tech Kopan Target (K915417), E-Z-Em PercuGuide I (K863090), E-Z-Em PercuGuide Lesion Marking device (K920816), and others. C. Device description: The Tumor…
Medical Device Technologies, Inc.1992—
*K863090Percu Guide I (Loop Type)
Summary page 1
…al equivalence: Manan Breast Tumor Localization Needle (K863848), Simon Breast Lesion Localization Needle (K914941), MD Tech Kopan Target (K915417), E-Z-Em PercuGuide I (K863090), E-Z-Em PercuGuide Lesion Marking device (K920816), and others. C. Device description: The TumorLocalizer MRI is a standard nee…
E-Z-Em, Inc.1986—
*K920816Percuguide Lesion Marking
Summary page 1
…dle (K863848), Simon Breast Lesion Localization Needle (K914941), MD Tech Kopan Target (K915417), E-Z-Em PercuGuide I (K863090), E-Z-Em PercuGuide Lesion Marking device (K920816), and others. C. Device description: The TumorLocalizer MRI is a standard needle and hookwire device used for the localization o…
E-Z-Em, Inc.1992—

Also cleared against K863848: 1 other device →

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 5 ancestors has a recall.
  • 1 other device also cites its predicate K863848.

How does its category compare?

All MIG devices

MIG Strip, Test Isoniazid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MIG

FDA has decided no MIG device since 2007.

Median 510(k) review, days · MIG

Too few MIG 510(k)s in any year since 2007 to give a median.

Recalls per year · MIG

No recall names MIG since 2007.

Adverse event reports per year · MIG

2in 2017

2017: 2
2007high 2 (2017) · low 0 (2007)2025

MAUDE reports naming product code MIG, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—02
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The device is intended for use to mark or identify, by standard radiologic techniques (X-Ray, fluoroscopy, CT, MRI) the location of a soft tissue abnormality such as a cyst, lesion, or tumor.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K863848

1 other device cites the same predicate.

  • K974741Manan Accura NeedleMedical Device Technologies, Inc. · 19981 recall

More from Ferguson Medical

57 FDA decisions under this applicant name. See the company

  • K033153Dicom TheaterFerguson Medical · 2004
  • K963794PunctureneedleFerguson Medical · 1998
  • K971813EMBLAFerguson Medical · 1998
  • K972219Orthopedic Plate SystemFerguson Medical · 1997
  • K972217Orthopedic Screw SystemFerguson Medical · 1997

Recent decisions in MIG

The MIG category page

  • K912888Uritec Test Strip & Human Urine + & - Test ControlDynagen, Inc. · 1992

https://510kreport.com/device/K962615 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962615: Tumorlocalizer Mri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962615

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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