510(k) · Cleared
ClearedNA Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · GDM Needle, Aspiration And Injection, Reusable
Cleared on Dec 12, 1990 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 68 devices in its family, counting itself, has a Class I recall. 67 later devices descend from it.
- Decided
- Dec 12, 1990
- Review
- 58 days
- Class
- Class I
- Product code
- GDM
- Recalls
- None
- Predicates
- 0
67 later devices descend from it, 2 citing it directly. 1 of the 68 devices in this family, counting this one, has a Class I recall.
- This deviceK904667 NA NeedlesOlympus Corp. · 1990
- Descendant · cites it directly · 65 of its ownK973128 Olympus NA-10J-1 Aspiration NeedleOlympus America, Inc. · 1997
- Descendant · 2 generations on · 63 of its ownK023272 Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002 · Recalled
- Descendant · 3 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- Descendant · 3 generations on · 27 of its ownK100712 Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · Recalled
- Descendant · 4 generations on · 26 of its ownK110030 Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · Recalled
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX6 generations on · 2020
Most influential descendants
Showing 5 of 67 · See all- K973128Olympus NA-10J-1 Aspiration NeedleOlympus America, Inc. · 1997 · cites it directly65descendants
- K023272Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002 · 2 generations on63descendants
- K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 3 generations on28descendants
- K100712Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · 3 generations on27descendants
- K110030Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · 4 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904667 | NA Needles | Olympus Corp. | 1990 | — |
| +1 | K973128 | Olympus NA-10J-1 Aspiration Needle | Olympus America, Inc. | 1997 | — |
| +2 | K023272 | Disposable Aspiration Needle NA-200H | The Olympus Optical Co. | 2002 | 1 |
| +3 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| +3 | K100712 | Resound Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2010 | 5 |
| +4 | K110030 | Expect Endoscopic Aspiration Needle | Boston Scientific Corp | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 1 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 7 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (67)
See all 672 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K973128 (Olympus America, Inc., 1997) has gone furthest, with 65 descendants of its own.
How does its category compare?
All GDM devicesGDM Needle, Aspiration And Injection, Reusable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDM
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GDM
Too few GDM 510(k)s in any year since 2007 to give a median.
Recalls per year · GDM
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GDM
5in 2025
MAUDE reports naming product code GDM, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 2 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K904667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904667: NA Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904667
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026