510(k) · Cleared
ClearedCoaptite Tissue Marker and Coaptite FN Tissue Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioform, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Oct 22, 2001 as substantially equivalent to K001807 (Advanced Uroscience, Inc., 2001) and 2 other predicates after a 48-day review. Its family tree reaches back 2 generations to 1997. 12 later devices descend from it.
- Decided
- Oct 22, 2001
- Review
- 48 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970817 (1997). 4 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970817 Micromark ClipBiopsys Medical, Inc. · 1997
- 1 generation backK983400 Auto Suture Site Marker ClipUnited States Surgical, A Division of Tyco Healthc · 1999
- This deviceK012955 Coaptite Tissue Marker and Coaptite FN Tissue MarkerBioform, Inc. · 2001
- Descendant · cites it directly · 10 of its ownK072219 Cytophil Tissue MarkerCytophil, Inc. · 2008
- Descendant · 2 generations on · 9 of its ownK093473 KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010
- Descendant · 3 generations on · 5 of its ownK130763 Beacon Tissue MarkerScion Medical Technologies, LLC · 2013
- Descendant · 3 generations on · 3 of its ownK140835 General and Plastic SurgeryScion Medical Technologies, LLC · 2014
- Descendant · 3 generations on · 1 of its ownK133697 Breast-Med Tissue MarkerBreast-Med, Inc. · 2015
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K072219Cytophil Tissue MarkerCytophil, Inc. · 2008 · cites it directly10descendants
- K093473KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010 · 2 generations on9descendants
- K130763Beacon Tissue MarkerScion Medical Technologies, LLC · 2013 · 3 generations on5descendants
- K140835General and Plastic SurgeryScion Medical Technologies, LLC · 2014 · 3 generations on3descendants
- K133697Breast-Med Tissue MarkerBreast-Med, Inc. · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970817 | Micromark Clip | Biopsys Medical, Inc. | 1997 | — |
| −1 | K983400 | Auto Suture Site Marker Clip | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| 0 (this device) | K012955 | Coaptite Tissue Marker and Coaptite FN Tissue Marker | Bioform, Inc. | 2001 | — |
| +1 | K072219 | Cytophil Tissue Marker | Cytophil, Inc. | 2008 | — |
| +2 | K093473 | KMD-MARK1 Tissue Marker | Kent Medical Devices, Inc. | 2010 | — |
| +3 | K130763 | Beacon Tissue Marker | Scion Medical Technologies, LLC | 2013 | — |
| +3 | K140835 | General and Plastic Surgery | Scion Medical Technologies, LLC | 2014 | — |
| +3 | K133697 | Breast-Med Tissue Marker | Breast-Med, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 K240042 MOLLI 2 Systemscore 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K001807 | Tissue MarkerSummary page 2…ification Submission Coaptite™ Tissue Marker Substantial Equivalence The following are predicate devices that are substantially equivalent to Coaptite™ Tissue Marker. K001807 Durasphere Tissue Marker Carbon Medical Technologies 1290 Hammond Road St. Paul, MN 55110 K000060 Gel Mark Biopsy Site Marker… | 2001 |
| * | K000060 | Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007Summary page 2…vices that are substantially equivalent to Coaptite™ Tissue Marker. K001807 Durasphere Tissue Marker Carbon Medical Technologies 1290 Hammond Road St. Paul, MN 55110 K000060 Gel Mark Biopsy Site Marker SenoRx, Inc. 13766 Alton Parkway, Suite 144 Irvine, CA 92618 K983400 Auto Suture Site Marker stap… | 2000 |
| * | K983400 | Auto Suture Site Marker ClipSummary page 2…er Carbon Medical Technologies 1290 Hammond Road St. Paul, MN 55110 K000060 Gel Mark Biopsy Site Marker SenoRx, Inc. 13766 Alton Parkway, Suite 144 Irvine, CA 92618 K983400 Auto Suture Site Marker staple United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856 Coaptite™ Tissue Marker… | 1999 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072219 (Cytophil, Inc., 2008) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K001807.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, 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 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
Coaptite™ Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012955: Coaptite Tissue Marker and Coaptite FN Tissue Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012955
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026