510(k) · Cleared
ClearedEchotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition 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 Mar 21, 2016 as substantially equivalent to K093195 (Cook Ireland, Ltd., 2010) and 1 other predicate after a 49-day review. Its family tree reaches back 10 generations to 1989. 2 of the 75 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Mar 21, 2016
- Review
- 49 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K894632 (1989). 67 ancestors in all, the oldest K812810 (1981). 7 later devices descend from it, 3 citing it directly. 2 of the 75 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 6 generations between
- 3 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 2 generations backK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- 1 generation backK093195 Echotip Ultra Endobronchial High Definition Ultasound Needle, Model…Cook Ireland, Ltd. · 2010
- This deviceK160229 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 · cites it directly · 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 · 2 generations on · 0 of its ownK261274 EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for…Cook Ireland, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251402 LIA-1 Catheter (542-1)Leadoptik, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 9 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 8 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 7 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 6 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 5 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 4 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 3 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 2 generations backK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- 1 generation backK093195 Echotip Ultra Endobronchial High Definition Ultasound Needle, Model…Cook Ireland, Ltd. · 2010
- This deviceK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- 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 · cites it directly2descendants
- 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 · 2 generations on0descendants
- K251402LIA-1 Catheter (542-1)Leadoptik, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −9 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −8 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −7 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −6 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −5 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −4 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| −3 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| −2 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| −1 | K093195 | Echotip Ultra Endobronchial High Definition Ultasound Needle, Model… | Cook Ireland, Ltd. | 2010 | — |
| 0 (this device) | 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 |
| +1 | 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 | — |
| +2 | K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes… | Cook Ireland, Ltd. | 2026 | — |
| +2 | K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 1 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K093195 | Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OSummary page 5…psy instrument (21 CFR 876.1075) Regulatory Class: II Product Code: FCG III. PREDICATE DEVICE Echotip® Ultra Endobronchial High Definition Ultrasound Needle, K093195 cleared January 21, 2010. Echotip Procore® High Definition Ultrasound Biopsy Needle, K142688 cleared December 19, 2014. None of t… | 2010 |
| * | K142688 | Echotip Procore HD Ultrasound Biopsy NeedleSummary page 5…ATE DEVICE Echotip® Ultra Endobronchial High Definition Ultrasound Needle, K093195 cleared January 21, 2010. Echotip Procore® High Definition Ultrasound Biopsy Needle, K142688 cleared December 19, 2014. None of the predicate devices detailed above have been subject to a design related recall. IV.… | 2014 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 17 of the 67 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210476 (Cook Ireland, Ltd., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Echotip® Ultra Endobronchial High Definition Ultrasound Needle for use with Olympus EBUS scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA). Echotip® Ultra Endobronchial High Definition Ultrasound Needle for use with Pentax EBUS scopes: This device is used to…
Read the full statement (172 words)
Echotip® Ultra Endobronchial High Definition Ultrasound Needle for use with Olympus EBUS scopes:
This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).
Echotip® Ultra Endobronchial High Definition Ultrasound Needle for use with Pentax EBUS scopes:
This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).
Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for use with Olympus EBUS scopes:
This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract.
Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for use with Pentax EBUS scopes:
This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition 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/K160229
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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