510(k) · Cleared
ClearedCytophil Tissue Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cytophil, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Jan 18, 2008 as substantially equivalent to K012955 (Bioform, Inc., 2001) after a 161-day review. Its family tree reaches back 3 generations to 1997. 10 later devices descend from it.
- Decided
- Jan 18, 2008
- Review
- 161 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970817 (1997). 5 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK970817 Micromark ClipBiopsys Medical, Inc. · 1997
- 2 generations backK983400 Auto Suture Site Marker ClipUnited States Surgical, A Division of Tyco Healthc · 1999
- 1 generation backK012955 Coaptite Tissue Marker and Coaptite FN Tissue MarkerBioform, Inc. · 2001
- This deviceK072219 Cytophil Tissue MarkerCytophil, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK093473 KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK130763 Beacon Tissue MarkerScion Medical Technologies, LLC · 2013
- Descendant · 2 generations on · 3 of its ownK140835 General and Plastic SurgeryScion Medical Technologies, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK133697 Breast-Med Tissue MarkerBreast-Med, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK251989 VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K093473KMD-MARK1 Tissue MarkerKent Medical Devices, Inc. · 2010 · cites it directly9descendants
- K130763Beacon Tissue MarkerScion Medical Technologies, LLC · 2013 · 2 generations on5descendants
- K140835General and Plastic SurgeryScion Medical Technologies, LLC · 2014 · 2 generations on3descendants
- K133697Breast-Med Tissue MarkerBreast-Med, Inc. · 2015 · 2 generations on1descendant
- K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970817 | Micromark Clip | Biopsys Medical, Inc. | 1997 | — |
| −2 | K983400 | Auto Suture Site Marker Clip | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| −1 | K012955 | Coaptite Tissue Marker and Coaptite FN Tissue Marker | Bioform, Inc. | 2001 | — |
| 0 (this device) | K072219 | Cytophil Tissue Marker | Cytophil, Inc. | 2008 | — |
| +1 | K093473 | KMD-MARK1 Tissue Marker | Kent Medical Devices, Inc. | 2010 | — |
| +2 | K130763 | Beacon Tissue Marker | Scion Medical Technologies, LLC | 2013 | — |
| +2 | K140835 | General and Plastic Surgery | Scion Medical Technologies, LLC | 2014 | — |
| +2 | K133697 | Breast-Med Tissue Marker | Breast-Med, Inc. | 2015 | — |
| +3 | K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. | 2025 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K012955 | Coaptite Tissue Marker and Coaptite FN Tissue MarkerSummary page 2…Imaging. 4.3 Substantial Equivalence The following is the predicate device that is substantially equivalent to the Cytophil Tissue Marker: K012955 Coaptite Tissue Marker and Coaptite FN Tissue Marker BioForm Medical, Inc. 1875 South Grant St., Suite 110… | 2001 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093473 | KMD-MARK1 Tissue Marker | 2010 | 9 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093473 (Kent Medical Devices, Inc., 2010) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K012955.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
Cytophil Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072219 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072219: Cytophil 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/K072219
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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