510(k) · Cleared
ClearedEchotip Procore HD Ultrasound Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · FCG Biopsy Needle
Cleared on Dec 19, 2014 as substantially equivalent to K083330 (Cook Endoscopy, 2009) and 1 other predicate after an 88-day review. Its family tree reaches back 5 generations to 1995. 1 of the 20 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Dec 19, 2014
- Review
- 88 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K935844 (1995). 10 ancestors in all, the oldest K822630 (1982). 9 later devices descend from it, 3 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- 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 deviceK142688 Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd. · 2014
- Descendant · cites it directly · 7 of its ownK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK210476 EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD…Cook Ireland, Ltd. · 2021 · Recalled
- Descendant · 2 generations on · 2 of its ownK193517 ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK230909 EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK261274 EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for…Cook Ireland, Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX2 generations on · 2020
Most influential descendants
Showing 5 of 9 · See all- K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd. · 2016 · cites it directly7descendants
- K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd. · 2021 · cites it directly2descendants
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 2 generations on2descendants
- K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd. · 2023 · 2 generations on1descendant
- K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd. · 2026 · 3 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) | K142688 | Echotip Procore HD Ultrasound Biopsy Needle | Cook Ireland, Ltd. | 2014 | — |
| +1 | K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore… | Cook Ireland, Ltd. | 2016 | — |
| +1 | K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound… | Cook Ireland, Ltd. | 2021 | 1 |
| +2 | K193517 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2020 | Class I |
| +2 | K230909 | EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | 2023 | — |
| +3 | K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes… | Cook Ireland, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 1 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 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 |
|---|---|---|---|
| * | K083330 | Echotip Ultra Ultrasound NeedleSummary page 5…Pg. 2 of 4 Cook Ireland EchoTip Procore® HD Ultrasound Biopsy Needle Page 2 of 4 III. PREDICATE DEVICE Cook Endoscopic Ultrasound Needle, K083330. Biopsy Sciences, LLC Maxi-Cell Biopsy Needle, K021847 IV. DEVICE DESCRIPTION The EchoTip Procore® HD Ultrasound Biopsy… | 2009 |
| * | K021847 | Biopsy Sciences, LLC. Maxi-Cell Biopsy NeedlesSummary page 5…ore® HD Ultrasound Biopsy Needle Page 2 of 4 III. PREDICATE DEVICE Cook Endoscopic Ultrasound Needle, K083330. Biopsy Sciences, LLC Maxi-Cell Biopsy Needle, K021847 IV. DEVICE DESCRIPTION The EchoTip Procore® HD Ultrasound Biopsy Needle is used in conjunction with an ultrasound endos… | 2002 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K160229 (Cook Ireland, Ltd., 2016) has gone furthest, with 7 descendants of its own.
- 8 other devices also cite its predicate K083330.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142688: Echotip Procore HD Ultrasound Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142688
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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