510(k) · Cleared

Cleared

Olympus NA-10J-1 Aspiration Needle

K973128510(k) TraditionalCleared Nov 18, 199789-day reviewClass I21 CFR 868.5700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Olympus America, Inc. · FOG Hood, Oxygen, Infant

Cleared on Nov 18, 1997 as substantially equivalent to K904667 (Olympus Corp., 1990) after an 89-day review. Its family tree reaches back 1 generation to 1990. 1 of the 67 devices in its family, counting itself, has a Class I recall. 65 later devices descend from it.

Decided: Nov 18, 1997
Review: 89 days
Class: Class I
Product code: FOG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K904667 (1990). 65 later devices descend from it, 3 citing it directly. 1 of the 67 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK904667 NA NeedlesOlympus Corp. · 1990
This deviceK973128 Olympus NA-10J-1 Aspiration NeedleOlympus America, Inc. · 1997
Descendant · cites it directly · 63 of its ownK023272 Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002 · Recalled
Descendant · 2 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
Descendant · 2 generations on · 27 of its ownK100712 Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · Recalled
Descendant · 3 generations on · 26 of its ownK110030 Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · Recalled
Descendant · 3 generations on · 16 of its ownK112198 Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2011

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

1999high 7 (2015) · low 0 (2000)2026

Class I recalls in this family

K193517 ViziShot 2 FLEX5 generations on · 2020

Most influential descendants

Showing 5 of 65 · See all

K023272Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002 · cites it directly63descendants
K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 2 generations on28descendants
K100712Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · 2 generations on27descendants
K110030Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · 3 generations on26descendants
K112198Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2011 · 3 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904667	NA Needles	Olympus Corp.	1990	—
0 (this device)	K973128	Olympus NA-10J-1 Aspiration Needle	Olympus America, Inc.	1997	—
+1	K023272	Disposable Aspiration Needle NA-200H	The Olympus Optical Co.	2002	1
+2	K050503	Single Use Aspiration Needle NA-201SX-4022	Olympus Medical Systems Corporation	2005	5
+2	K100712	Resound Endoscopic Ultrasound Aspiration Needle	Boston Scientific Corporation	2010	5
+3	K110030	Expect Endoscopic Aspiration Needle	Boston Scientific Corp	2011	1
+3	K112198	Expect Endoscopic Ultrasound Aspiration Needle	Boston Scientific Corporation	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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

FIG. 1 — Lineage of K973128, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K904667	NA Needles Summary page 1 …nt of Intended Use: Olympus NA-10J-1 Aspiration Needle Biopsy Instruments 21 CFR 876.1075 Gastroenterology-Urology Biopsy Instruments Olympus NA-1C Aspiration Needle (K904667) Linda L. Favata Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 (516) 844-54…	Olympus Corp.	1990	—

Also cleared against K904667: 1 other device →

What descends from it? (65)

See all 65

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023272	Disposable Aspiration Needle NA-200H	The Olympus Optical Co.	2002	63
K151738	Single Use Aspiration Needle NA-U200H	Olympus Medical Systems Corp.	2015	3
K991672	Olympus NA-10J-KB Aspiration Needle	Olympus America, Inc.	1999	0

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 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K023272 (The Olympus Optical Co., 2002) has gone furthest, with 63 descendants of its own.
1 other device also cites its predicate K904667.

How does its category compare?

All FOG devices

FOG Hood, Oxygen, Infant: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOG

FDA has decided no FOG device since 2007.

Median 510(k) review, days · FOG

Too few FOG 510(k)s in any year since 2007 to give a median.

Recalls per year · FOG

No recall names FOG since 2007.

Adverse event reports per year · FOG

3in 2008

2007high 3 (2008) · low 0 (2007)2025

MAUDE reports naming product code FOG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	3
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-rectal masses, and lymph nodes).

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/K973128 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973128: Olympus NA-10J-1 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/K973128

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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