510(k) · Cleared
ClearedAreus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic Ultrasound Aspiration Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Dec 6, 2021 as substantially equivalent to K172309 (Micro-Tech (Nanjing) Co., Ltd., 2017) after a 90-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Dec 6, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- ODG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904667 (1990). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK904667 NA NeedlesOlympus Corp. · 1990
- 7 generations backK973128 Olympus NA-10J-1 Aspiration NeedleOlympus America, Inc. · 1997
- 6 generations backK023272 Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002 · Recalled
- 5 generations backK100712 Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · Recalled
- 4 generations backK110030 Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · Recalled
- 3 generations backK133312 Expect Slimline Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2014
- 2 generations backK160845 Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation · 2016
- 1 generation backK172309 Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. · 2017 · Recalled
- This deviceK212852 Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt…Micro-Tech (Nanjing) Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904667 | NA Needles | Olympus Corp. | 1990 | — |
| −7 | K973128 | Olympus NA-10J-1 Aspiration Needle | Olympus America, Inc. | 1997 | — |
| −6 | K023272 | Disposable Aspiration Needle NA-200H | The Olympus Optical Co. | 2002 | 1 |
| −5 | K100712 | Resound Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2010 | 5 |
| −4 | K110030 | Expect Endoscopic Aspiration Needle | Boston Scientific Corp | 2011 | 1 |
| −3 | K133312 | Expect Slimline Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2014 | — |
| −2 | 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 |
| 0 (this device) | 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 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K172309 | Endoscopic Ultrasound Aspiration NeedleSummary page 5…Section 5 510(k) Summary 4. Identification of Predicate Device Predicate Device 510(k) Number: K172309 Product Name: Endoscopic Ultrasound Aspiration Needle Manufacturer: Micro-Tech (Nanjing) Co., Ltd.… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 7 of the 18 ancestors have a recall of any class.
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. 2021, 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 device is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212852 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212852: Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) 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/K212852
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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