510(k) · Cleared
ClearedAcquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on May 3, 2016 as substantially equivalent to K133312 (Boston Scientific Corporation, 2014) after a 36-day review. Its family tree reaches back 6 generations to 1990. 4 later devices descend from it.
- Decided
- May 3, 2016
- Review
- 36 days
- Class
- Class II
- Product code
- ODG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904667 (1990). 9 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK904667 NA NeedlesOlympus Corp. · 1990
- 5 generations backK973128 Olympus NA-10J-1 Aspiration NeedleOlympus America, Inc. · 1997
- 4 generations backK023272 Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002 · Recalled
- 3 generations backK100712 Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · Recalled
- 2 generations backK110030 Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · Recalled
- 1 generation backK133312 Expect Slimline Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2014
- This deviceK160845 Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation · 2016
- Descendant · cites it directly · 1 of its ownK172309 Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK251542 InstaFANOnepass Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK223616 Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK212852 Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt…Micro-Tech (Nanjing) Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. · 2017 · cites it directly1descendant
- K251542InstaFANOnepass Medical, Ltd. · 2025 · cites it directly0descendants
- K223616Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation · 2022 · cites it directly0descendants
- K212852Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic…Micro-Tech (Nanjing) Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904667 | NA Needles | Olympus Corp. | 1990 | — |
| −5 | K973128 | Olympus NA-10J-1 Aspiration Needle | Olympus America, Inc. | 1997 | — |
| −4 | K023272 | Disposable Aspiration Needle NA-200H | The Olympus Optical Co. | 2002 | 1 |
| −3 | K100712 | Resound Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2010 | 5 |
| −2 | K110030 | Expect Endoscopic Aspiration Needle | Boston Scientific Corp | 2011 | 1 |
| −1 | K133312 | Expect Slimline Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2014 | — |
| 0 (this device) | K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | 2016 | — |
| +1 | K172309 | Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2017 | 2 |
| +1 | K251542 | InstaFAN | Onepass Medical, Ltd. | 2025 | — |
| +1 | K223616 | Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | 2022 | — |
| +2 | K212852 | Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM)… | Micro-Tech (Nanjing) Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 ODG? 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 ODG device
- #1 K251859 EVIS EUS Ultrasound Gastrointestinal…score 14.0 · 4 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 |
|---|---|---|---|
| * | K133312 | Expect Slimline Endoscopic Ultrasound Aspiration NeedleSummary page 4…ss II 3. Predicate Device: Trade Name: Expect™ Slimline Endoscopic Ultrasound Aspiration Needle Manufacturer and Clearance Number: Boston Scientific Corp, K133312 Classification Name: Endoscopic ultrasound system, gastroenterology-urology Regulation Number: 876.1500 & 876.1075… | 2014 |
What descends from it? (4)
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 26 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K172309 (Micro-Tech (Nanjing) Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K133312.
How does its category compare?
All ODG devicesODG Endoscopic Ultrasound System, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · ODG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODG
71in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODG
4in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODG
3,569in 2025
MAUDE reports naming product code ODG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 1 | — | 0 | 50 |
| 2017 | 4 | 75 | 0 | 82 |
| 2018 | 3 | 30 | 0 | 66 |
| 2019 | 1 | — | 0 | 96 |
| 2020 | 2 | — | 4 | 445 |
| 2021 | 1 | — | 0 | 1,234 |
| 2022 | 4 | 71 | 0 | 1,832 |
| 2023 | 1 | — | 0 | 2,078 |
| 2024 | 1 | — | 0 | 1,904 |
| 2025 | 2 | — | 0 | 3,569 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The Acquire™ Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160845: Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160845
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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