510(k) Report

510(k) · Cleared

Cleared

Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376

K033447510(k) TraditionalCleared Jan 28, 200491-day reviewClass II21 CFR 878.4300

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

Mri Devices Corp. · NEU Marker, Radiographic, Implantable

Cleared on Jan 28, 2004 as substantially equivalent to K970817 (Biopsys Medical, Inc., 1997) and 5 other predicates after a 91-day review. Its family tree reaches back 2 generations to 1997. 25 later devices descend from it.

Decided
Jan 28, 2004
Review
91 days
Class
Class II
Product code
NEU
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K970817 (1997). 6 ancestors in all. 25 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors2001: 1 other ancestor2000: 1 other ancestor2008: 1 descendant cleared2010: 1 descendant cleared2007: 1 descendant cleared2021: 3 descendants cleared2011: 1 descendant cleared2024: 3 descendants cleared2018: 4 descendants cleared2012: 1 descendant cleared2013: 2 descendants cleared2016: 1 descendant cleared2023: 4 descendants cleared2017: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant clearedK970817 · Micromark Clip · Biopsys Medical, Inc. · 1997K993785 · Ultraclip Tissue Marker · Inrad · 2000 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 3 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 2 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K993785 · Ultraclip Tissue Marker · Inrad · 2000 · recalledK970817 · Micromark Clip · Biopsys Medical, Inc. · 19970+5+10
  1. Root · 2 generations backK970817 Micromark ClipBiopsys Medical, Inc. · 1997
  2. 1 generation backK993785 Ultraclip Tissue MarkerInrad · 2000 · Recalled
  3. This deviceK033447 Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM…Mri Devices Corp. · 2004
  4. Descendant · cites it directly · 23 of its ownK073095 Tumark Professional, Model 271560; MR- Tumark Professional, Model…Somatex Medical Technologies GmbH · 2008 · Recalled
  5. Descendant · cites it directly · 21 of its ownK093064 Tumark Professional, Model 271560, MR-Tumark Professional, Model…Somatex Medical Technologies GmbH · 2010
  6. Descendant · 2 generations on · 16 of its ownK111692 Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011
  7. Descendant · 3 generations on · 15 of its ownK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013
  8. Descendant · 4 generations on · 13 of its ownK153044 Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12010: 12011: 12012: 12013: 22016: 12017: 12018: 42021: 32022: 12023: 42024: 32025: 1
2007high 4 (2018) · low 0 (2009)2026

Most influential descendants

Showing 5 of 25 · See all
  • K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 2008 · cites it directly23descendants
  • K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 2010 · cites it directly21descendants
  • K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011 · 2 generations on16descendants
  • K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013 · 3 generations on15descendants
  • K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K970817Micromark ClipBiopsys Medical, Inc.1997—
−1K993785Ultraclip Tissue MarkerInrad20001
0 (this device)K033447Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models…Mri Devices Corp.2004—
+1K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH20081
+1K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH2010—
+2K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH2011—
+3K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical2013—
+4K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201010
201110
201210
201320
201610
201710
201840
202130
202210
202340
202430
202510
FIG. 1 — Lineage of K033447, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 NEU? 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 NEU device

  1. #1 K240042 MOLLI 2 Systemscore 14.4 · 12 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? (6)

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
*K970817Micromark Clip
Summary page 1
…c Soft Tissue Marker Classification Name: Implantable Staple Predicate Devices TM Biopsys Medical, Inc (BMI) MicroMark Clip (K970817) Inrad, Inc UltraClip Tissue Marker (K993785) Ethicon Endo-Surgery, Inc MicroMark IITM Tissue Marker (K013413) Ethicon Endo-Surge…
Biopsys Medical, Inc.1997—
*K993785Ultraclip Tissue Marker
Summary page 1
…Implantable Staple Predicate Devices TM Biopsys Medical, Inc (BMI) MicroMark Clip (K970817) Inrad, Inc UltraClip Tissue Marker (K993785) Ethicon Endo-Surgery, Inc MicroMark IITM Tissue Marker (K013413) Ethicon Endo-Surgery, Inc 8 Gauge MicroMark IITM Tissue Marker…
Inrad20001
*K013413Micromark II Tissue Marker,Model C1535
Summary page 1
…TM Biopsys Medical, Inc (BMI) MicroMark Clip (K970817) Inrad, Inc UltraClip Tissue Marker (K993785) Ethicon Endo-Surgery, Inc MicroMark IITM Tissue Marker (K013413) Ethicon Endo-Surgery, Inc 8 Gauge MicroMark IITM Tissue Marker (K020276) Sanarus Medical, Inc Sanarus Indica Marker System (K020…
Ethicon Endo-Surgery, Inc.2001—
*K0202768 Gauge Micromark II Tissue Marker, Models C1540 & C1535
Summary page 1
…d, Inc UltraClip Tissue Marker (K993785) Ethicon Endo-Surgery, Inc MicroMark IITM Tissue Marker (K013413) Ethicon Endo-Surgery, Inc 8 Gauge MicroMark IITM Tissue Marker (K020276) Sanarus Medical, Inc Sanarus Indica Marker System (K020054) Vivant Medical, Inc VMI Biopsy Marker System (K000278) Device Descr…
Ethicon Endo-Surgery, Inc.2002—
*K020054Sanarus Indica Marker System
Summary page 1
…y, Inc MicroMark IITM Tissue Marker (K013413) Ethicon Endo-Surgery, Inc 8 Gauge MicroMark IITM Tissue Marker (K020276) Sanarus Medical, Inc Sanarus Indica Marker System (K020054) Vivant Medical, Inc VMI Biopsy Marker System (K000278) Device Description The ClipLoc Soft Tissue Marker is a sterile, single p…
Sanarus Medical, Inc.2002—
*K000278Vivant Medical Biopsy Marker System
Summary page 1
…ndo-Surgery, Inc 8 Gauge MicroMark IITM Tissue Marker (K020276) Sanarus Medical, Inc Sanarus Indica Marker System (K020054) Vivant Medical, Inc VMI Biopsy Marker System (K000278) Device Description The ClipLoc Soft Tissue Marker is a sterile, single patient use device comprised of a small nickel- titanium…
Vivant Medical, Inc.2000—

Also cleared against K970817: 3 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH200823
K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH201021
K072216Kapp Bari-Ring Endoscopic Marker, Model K-9536Kapp Surgical Instrument, Inc.20070

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?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K073095 (Somatex Medical Technologies GmbH, 2008) has gone furthest, with 23 descendants of its own.
  • 3 other devices also cite its predicate K970817.

How does its category compare?

All NEU devices

NEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NEU

5in 2025

2007: 42008: 72009: 42010: 52011: 32012: 32013: 72014: 32015: 72016: 22017: 42018: 82019: 52020: 32021: 32022: 22023: 42024: 102025: 52026 (partial year): 1
2007high 10 (2024) · low 2 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEU

99in 2025

2007: 94 days median2008: 107 days median2009: 70 days median2010: 69 days median2011: 145 days median2012: 120 days median2013: 49 days median2014: 48 days median2015: 111 days median2017: 115 days median2018: 89 days median2019: 149 days median2020: 169 days median2021: 46 days median2023: 136 days median2024: 267 days median2025: 99 days median
2007high 267 (2024) · low 46 (2021)2026

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

Recalls per year · NEU

2in 2025

2011: 12017: 12022: 12024: 2, 1 Class I2025: 22026 (partial year): 2
2007high 2 (2024) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NEU

411in 2025

2007: 52008: 52009: 302010: 122011: 182012: 542013: 602014: 382015: 1202016: 562017: 692018: 662019: 582020: 452021: 822022: 1002023: 1422024: 2472025: 411
2007high 411 (2025) · low 5 (2007)2025

MAUDE reports naming product code NEU, 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
200749405
2008710705
2009470030
2010569012
20113145118
20123120054
2013749060
2014348038
201571110120
20162—056
20174115169
2018889066
20195149058
20203169045
2021346082
20222—1100
202341360142
2024102672 (1)247
20255992411
20261—2—

What is it indicated for?

The ClipLoc TM Soft Tissue Marker is indicated for use to radiographically and radiologically mark the surgical location in breast or other soft tissue following an open or percutaneous procedure.

It is intended to attach to soft tissue, including breast tissue, at the surgical site during an open or percutaneous procedure.

Indications for use as stated in the FDA summary.

Also cleared against K970817

3 other devices cite the same predicate.

  • K060769Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
  • K993785Ultraclip Tissue MarkerInrad · 20001 recall
  • K983400Auto Suture Site Marker ClipUnited States Surgical, A Division of Tyco Healthc · 1999

More from Mri Devices Corp.

71 FDA decisions under this applicant name. See the company

  • K041286Dynacad V1.0Mri Devices Corp. · 2004
  • K041481Model BBC-127 Biopsy Breast CoilMri Devices Corp. · 20041 recall
  • K040348Modification to HNC-127-Int Neurovascular Array CoilMri Devices Corp. · 2004
  • K040349Modification to HRW-127 Wrist Array CoilMri Devices Corp. · 2004
  • K040288QSC-127-Int Shoulder Array Coil SetMri Devices Corp. · 2004

Recent decisions in NEU

The NEU category page

  • K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker…Devicor Medical Products, Inc. · 2026
  • K253888MOLLI 2 SystemStryker Endoscopy · 20251 recall
  • K252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc. · 20251 recall
  • K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc. · 2025
  • K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc. · 2025

https://510kreport.com/device/K033447 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033447: Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033447

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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