510(k) · Cleared
ClearedInstaFAN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onepass Medical, Ltd. · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Jul 18, 2025 as substantially equivalent to K160845 (Boston Scientific Corporation, 2016) after a 59-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Jul 18, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- ODG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904667 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK904667 NA NeedlesOlympus Corp. · 1990
- 6 generations backK973128 Olympus NA-10J-1 Aspiration NeedleOlympus America, Inc. · 1997
- 5 generations backK023272 Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002 · Recalled
- 4 generations backK100712 Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · Recalled
- 3 generations backK110030 Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · Recalled
- 2 generations backK133312 Expect Slimline Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2014
- 1 generation backK160845 Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation · 2016
- This deviceK251542 InstaFANOnepass Medical, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904667 | NA Needles | Olympus Corp. | 1990 | — |
| −6 | K973128 | Olympus NA-10J-1 Aspiration Needle | Olympus America, Inc. | 1997 | — |
| −5 | K023272 | Disposable Aspiration Needle NA-200H | The Olympus Optical Co. | 2002 | 1 |
| −4 | K100712 | Resound Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2010 | 5 |
| −3 | K110030 | Expect Endoscopic Aspiration Needle | Boston Scientific Corp | 2011 | 1 |
| −2 | 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 | — |
| 0 (this device) | K251542 | InstaFAN | Onepass Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceSummary page 5….1500 Product Code(s) ODG, FCG | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K160845 Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) oDG Device Device Description Summary 21 CFR 807.92(a)(4) InstaFAN is an… | 2016 |
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 35 years and passes through 6 companies; a new generation was cleared every 5.1 years on median.
- 5 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K160845.
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. 2025, 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 InstaFAN device is intended for sampling targeted submucosal and extramural lesions within or adjacent to the gastrointestinal tract through the accessory channel of a curvilinear echo-endoscope. Use only with EUS endoscopes.
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/K251542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251542: InstaFAN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251542
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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