510(k) · Cleared
ClearedMedi-Globe Sonotip II Ebus-Tbna Needle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Globe Corporation · FCG Biopsy Needle
Cleared on May 8, 2009 as substantially equivalent to K070129 (Medi-Globe Corporation, 2007) and 2 other predicates after a 9-day review. Its family tree reaches back 9 generations to 1989. 1 of the 63 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- May 8, 2009
- Review
- 9 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K894632 (1989). 59 ancestors in all, the oldest K812810 (1981). 3 later devices descend from it, 1 citing it directly. 1 of the 63 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 5 generations between
- 3 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 2 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 1 generation backK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- This deviceK091257 Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation · 2009
- Descendant · cites it directly · 2 of its ownK133763 Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation · 2014
- Descendant · 2 generations on · 1 of its ownK231267 ClearTipFinemedix Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK250994 ClearTip FNA and FNB TypesFinemedix Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 8 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 7 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 6 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 5 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 4 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 3 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 2 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 1 generation backK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- This deviceK091257 Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation · 2009
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…4 generations back · 2003
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −8 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −7 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −6 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −5 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −4 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −3 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| −2 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| −1 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| 0 (this device) | K091257 | Medi-Globe Sonotip II Ebus-Tbna Needle System | Medi-Globe Corporation | 2009 | — |
| +1 | K133763 | Sonotip Pro and Pro Flex Ebus-Tbna Needle System | Medi-Globe Corporation | 2014 | — |
| +2 | K231267 | ClearTip | Finemedix Co., Ltd. | 2023 | — |
| +3 | K250994 | ClearTip FNA and FNB Types | Finemedix Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 1 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2023 | 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.
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? (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 |
|---|---|---|---|
| * | K070129 | Sonotip II Ultrasound Needle SystemSummary page 1…lobe.com B. Device Name: Medi-Globe SonoTip II EBUS-TBNA Needle System C. Predicate Devices: Medi-Globe SonoTip II Ultrasound Needle System (K070129) Medi-Globe SonoTip II Ultrasound Needle System (K051247) Olympus Medical Single Use Aspiration Needle NA-201 S… | 2007 |
| * | K051247 | Sonotip II Ultrasound Needle SystemSummary page 1…-TBNA Needle System C. Predicate Devices: Medi-Globe SonoTip II Ultrasound Needle System (K070129) Medi-Globe SonoTip II Ultrasound Needle System (K051247) Olympus Medical Single Use Aspiration Needle NA-201 SX-4022, (K050503) D. Device Description: The Medi-G… | 2005 |
| * | K050503 | Single Use Aspiration Needle NA-201SX-4022Summary page 1…trasound Needle System (K070129) Medi-Globe SonoTip II Ultrasound Needle System (K051247) Olympus Medical Single Use Aspiration Needle NA-201 SX-4022, (K050503) D. Device Description: The Medi-Globe SonoTip II EBUS-TBNA Needle System is a complete one-piece needle s… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133763 | Sonotip Pro and Pro Flex Ebus-Tbna Needle System | 2014 | 2 |
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 17 of the 59 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133763 (Medi-Globe Corporation, 2014) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K070129.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The SonoTip II Endobronchial Ultrasound-Guided Transbronchial Fine Needle Aspiration, (EBUS-TBNA) Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II EBUS-TBNA Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091257 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091257: Medi-Globe Sonotip II Ebus-Tbna Needle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091257
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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