510(k) Report

510(k) · Cleared

Cleared

Sanarus Indica Marker System

K020054510(k) TraditionalCleared Oct 16, 2002281-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

Sanarus Medical, Inc. · FZP Clip, Implantable

Cleared on Oct 16, 2002 after a 281-day review. The FDA summary names no predicate by number. 26 later devices descend from it.

Decided
Oct 16, 2002
Review
281 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
0

26 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2008: 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 clearedReference device: K000060 · Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007 · Senorx, Inc. · 2000Reference device: K001807 · Tissue Marker · Advanced Uroscience, Inc. · 2001Reference device: K993785 · Ultraclip Tissue Marker · Inrad · 2000 · recalled200020052010201520202025
  1. This deviceK020054 Sanarus Indica Marker SystemSanarus Medical, Inc. · 2002
  2. Descendant · cites it directly · 25 of its ownK033447 Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM…Mri Devices Corp. · 2004
  3. Descendant · 2 generations on · 23 of its ownK073095 Tumark Professional, Model 271560; MR- Tumark Professional, Model…Somatex Medical Technologies GmbH · 2008 · Recalled
  4. Descendant · 2 generations on · 21 of its ownK093064 Tumark Professional, Model 271560, MR-Tumark Professional, Model…Somatex Medical Technologies GmbH · 2010
  5. Descendant · 3 generations on · 16 of its ownK111692 Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011
  6. Descendant · 4 generations on · 15 of its ownK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12008: 12010: 12011: 12012: 12013: 22016: 12017: 12018: 42021: 32022: 12023: 42024: 32025: 1
2004high 4 (2018) · low 0 (2005)2026

Most influential descendants

Showing 5 of 26 · See all
  • K033447Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370…Mri Devices Corp. · 2004 · cites it directly25descendants
  • K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 2008 · 2 generations on23descendants
  • K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 2010 · 2 generations on21descendants
  • K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011 · 3 generations on16descendants
  • K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013 · 4 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020054Sanarus Indica Marker SystemSanarus Medical, Inc.2002—
+1K033447Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models…Mri Devices Corp.2004—
+2K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH20081
+2K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH2010—
+3K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH2011—
+4K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
200810
201010
201110
201210
201320
201610
201710
201840
202130
202210
202340
202430
202510
FIG. 1 — Lineage of K020054, 2002–2025Source: 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 FZP? 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 FZP device

  1. #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 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?

The FDA summary names no predicate by number.

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K033447Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370…Mri Devices Corp.200425

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, K033447 (Mri Devices Corp., 2004) has gone furthest, with 25 descendants of its own.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZP

5in 2025

2007: 62008: 42009: 32010: 62011: 32012: 22013: 32014: 32015: 82016: 52017: 42018: 42019: 12020: 22022: 32023: 32024: 22025: 52026 (partial year): 2
2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007: 31 days median2008: 23 days median2009: 22 days median2010: 47 days median2011: 124 days median2013: 47 days median2014: 29 days median2015: 182 days median2016: 72 days median2017: 29 days median2018: 143 days median2022: 227 days median2023: 65 days median2025: 90 days median
2007high 227 (2022) · low 22 (2009)2026

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

Recalls per year · FZP

1in 2020

2007: 12008: 62010: 12012: 12014: 12016: 22017: 12019: 32020: 1
2007high 6 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FZP

1,902in 2025

2007: 1,8772008: 9812009: 2,1602010: 2,3672011: 1,6782012: 1,6772013: 2,3812014: 2,3202015: 2,8712016: 1,8402017: 2,5942018: 2,7182019: 2,9032020: 1,7602021: 1,7592022: 1,5752023: 1,9182024: 2,0672025: 1,902
2007high 2,903 (2019) · low 981 (2008)2025

MAUDE reports naming product code FZP, 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
200763111,877
20084236981
200932202,160
201064712,367
2011312401,678
20122—11,677
201334702,381
201432912,320
2015818202,871
201657221,840
201742912,594
2018414302,718
20191—32,903
20202—11,760
20210—01,759
2022322701,575
202336501,918
20242—02,067
202559001,902
20262—0—

What is it indicated for?

The Sanarus Indica Marker System is indicated for use to attach to soft tissue, including breast tissue, following an open surgical or percutaneous biopsy procedure and to radiographically and radiologically mark the location of the biopsy procedure.

Indications for use as stated in the FDA summary.

More from Sanarus Medical, Inc.

14 FDA decisions under this applicant name. See the company

  • K080171Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012Sanarus Medical, Inc. · 2008
  • K073533Sanarus V2 Treatment SystemSanarus Medical, Inc. · 2008
  • K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600Sanarus Medical, Inc. · 2007
  • K061510Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
  • K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005

Recent decisions in FZP

The FZP category page

  • K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. · 2026
  • K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026
  • K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
  • K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
  • K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025

https://510kreport.com/device/K020054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020054: Sanarus Indica Marker System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020054

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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