510(k) · Cleared
ClearedExpect Slimline Endoscopic Ultrasound Aspiration Needle
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 Jan 3, 2014 as substantially equivalent to K110030 (Boston Scientific Corp, 2011) after a 67-day review. Its family tree reaches back 5 generations to 1990. 8 later devices descend from it.
- Decided
- Jan 3, 2014
- Review
- 67 days
- Class
- Class II
- Product code
- ODG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904667 (1990). 8 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK904667 NA NeedlesOlympus Corp. · 1990
- 4 generations backK973128 Olympus NA-10J-1 Aspiration NeedleOlympus America, Inc. · 1997
- 3 generations backK023272 Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002 · Recalled
- 2 generations backK100712 Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · Recalled
- 1 generation backK110030 Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · Recalled
- This deviceK133312 Expect Slimline Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2014
- Descendant · cites it directly · 4 of its ownK160845 Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation · 2016
- Descendant · 2 generations on · 1 of its ownK172309 Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK163058 Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017
- Descendant · 2 generations on · 0 of its ownK251542 InstaFANOnepass Medical, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK223616 Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K160845Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation · 2016 · cites it directly4descendants
- K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. · 2017 · 2 generations on1descendant
- K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017 · cites it directly1descendant
- K251542InstaFANOnepass Medical, Ltd. · 2025 · 2 generations on0descendants
- K223616Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904667 | NA Needles | Olympus Corp. | 1990 | — |
| −4 | K973128 | Olympus NA-10J-1 Aspiration Needle | Olympus America, Inc. | 1997 | — |
| −3 | K023272 | Disposable Aspiration Needle NA-200H | The Olympus Optical Co. | 2002 | 1 |
| −2 | K100712 | Resound Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2010 | 5 |
| −1 | K110030 | Expect Endoscopic Aspiration Needle | Boston Scientific Corp | 2011 | 1 |
| 0 (this device) | K133312 | Expect Slimline Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2014 | — |
| +1 | K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | 2016 | — |
| +2 | K172309 | Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2017 | 2 |
| +1 | K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017 | — |
| +2 | K251542 | InstaFAN | Onepass Medical, Ltd. | 2025 | — |
| +2 | K223616 | Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | 2022 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110030 | Expect Endoscopic Aspiration NeedleSummary page 2…n feature and modified handle internal components. The currently cleared ExpectTm EUS-ENA needle is composed of an ergonomic handle with bigger outer diameter (1(110030 & 1(112198). 7. Performance Data: Bench Testing has been performed on the proposed Expect m Slimldine device, which demo… | 2011 |
| Kept off the family tree | K121198 | FDA’s K121198 is BW685, BW685S Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
What descends from it? (8)
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 24 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K160845 (Boston Scientific Corporation, 2016) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K110030.
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. 2014, 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 Expect™ Slimline (SL) Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133312: Expect Slimline Endoscopic Ultrasound Aspiration Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133312
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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