510(k) · Cleared
ClearedEchotip (R) Ultra Fiducial Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical Inc./Cook Endoscopy · NEU Marker, Radiographic, Implantable
Cleared on Apr 27, 2012 as substantially equivalent to K042296 (Carbon Medical Technologies, Inc., 2004) and 1 other predicate after a 297-day review. Its family tree reaches back 5 generations to 1995. 10 later devices descend from it.
- Decided
- Apr 27, 2012
- Review
- 297 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K935844 (1995). 11 ancestors in all, the oldest K934356 (1994). 10 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 4 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 3 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 2 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 1 generation backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- This deviceK111895 Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012
- Descendant · cites it directly · 5 of its ownK142198 BNX Fine Needle Aspiration SystemCovidien, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK150891 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle…Covidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015
- Descendant · cites it directly · 2 of its ownK132708 Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK163058 Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017
- Descendant · 2 generations on · 0 of its ownK191797 BiomarC Fiducial MarkerCarbon Medical Technologies · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142198BNX Fine Needle Aspiration SystemCovidien, LLC · 2014 · cites it directly5descendants
- K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015 · 2 generations on3descendants
- K132708Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 2013 · cites it directly2descendants
- K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017 · 3 generations on1descendant
- K191797BiomarC Fiducial MarkerCarbon Medical Technologies · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −4 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −3 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −2 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −1 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| 0 (this device) | K111895 | Echotip (R) Ultra Fiducial Needle | Wilson-Cook Medical Inc./Cook Endoscopy | 2012 | — |
| +1 | K142198 | BNX Fine Needle Aspiration System | Covidien, LLC | 2014 | — |
| +2 | K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | Covidien, LLC ( Formerly Beacon Endoscopic Corp.) | 2015 | — |
| +1 | K132708 | Biomarc Fiducial Marker | Carbon Medical Technologies, Inc. | 2013 | — |
| +3 | K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017 | — |
| +2 | K191797 | BiomarC Fiducial Marker | Carbon Medical Technologies | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K042296 | Biomarc Preloaded Tissue Marker DeviceSummary page 1…Kit, Needle, Biopsy 21 CFR 876.1075, FCG, Class 11. Predicate Devices BiomarC® Preloaded Tissue Marker Device, 510(k) No. K042296, cleared September 20, 2004 EchoTip® Ultra Ultrasound Needle, 5 10(k) No. K083330, cleared February 6, 2009 Intended Use, This… | 2004 |
| * | K083330 | Echotip Ultra Ultrasound NeedleSummary page 1…FCG, Class 11. Predicate Devices BiomarC® Preloaded Tissue Marker Device, 510(k) No. K042296, cleared September 20, 2004 EchoTip® Ultra Ultrasound Needle, 5 10(k) No. K083330, cleared February 6, 2009 Intended Use, This device is intended to implant fiducials under endoscopic ultrasound to radiographi… | 2009 |
What descends from it? (10)
3 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 17 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K142198 (Covidien, LLC, 2014) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K042296.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Intended to implant fiducials under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111895: Echotip (R) Ultra Fiducial Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111895
Report an extraction error
Are you the manufacturer?
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