510(k) · Cleared
Recalled · Class II · 2021Disposable Aspiration Needle NA-200H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Olympus Optical Co. · FCG Biopsy Needle
Cleared on Dec 23, 2002 as substantially equivalent to K973128 (Olympus America, Inc., 1997) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1990. 1 of the 68 devices in its family, counting itself, has a Class I recall. 63 later devices descend from it. It has been recalled once.
- Decided
- Dec 23, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- FCG
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K904667 (1990). 4 ancestors in all. 63 later devices descend from it, 4 citing it directly. 1 of the 68 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK904667 NA NeedlesOlympus Corp. · 1990
- 1 generation backK973128 Olympus NA-10J-1 Aspiration NeedleOlympus America, Inc. · 1997
- This deviceK023272 Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002
- Descendant · cites it directly · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- Descendant · cites it directly · 27 of its ownK100712 Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · Recalled
- Descendant · 2 generations on · 26 of its ownK110030 Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · Recalled
- Descendant · 2 generations on · 16 of its ownK112198 Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2011
- Descendant · 3 generations on · 11 of its ownK123676 Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX4 generations on · 2020
Most influential descendants
Showing 5 of 63 · See all- K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · cites it directly28descendants
- K100712Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · cites it directly27descendants
- K110030Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · 2 generations on26descendants
- K112198Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2011 · 2 generations on16descendants
- K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies · 2013 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904667 | NA Needles | Olympus Corp. | 1990 | — |
| −1 | K973128 | Olympus NA-10J-1 Aspiration Needle | Olympus America, Inc. | 1997 | — |
| 0 (this device) | K023272 | Disposable Aspiration Needle NA-200H | The Olympus Optical Co. | 2002 | — |
| +1 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| +1 | K100712 | Resound Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2010 | 5 |
| +2 | K110030 | Expect Endoscopic Aspiration Needle | Boston Scientific Corp | 2011 | 1 |
| +2 | K112198 | Expect Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2011 | — |
| +3 | K123676 | Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes | Mauna Kea Technologies | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
Top candidate predicates for a new FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K973128 | Olympus NA-10J-1 Aspiration NeedleSummary page 1…quivalence Description Model No Manufacturer #K ASPIRATION NEEDLE NA-IOJ-1 OlvmDus ODtical Co.. Ltd. K973128 VACLOK Syringe - Merit Medical System Inc. K994253 STOPCOCK(0ne-port manifold) -… | 1997 |
| * | K994253 | Vaclok SyringeSummary page 1…#K ASPIRATION NEEDLE NA-IOJ-1 OlvmDus ODtical Co.. Ltd. K973128 VACLOK Syringe - Merit Medical System Inc. K994253 STOPCOCK(0ne-port manifold) - Merit Medical System Inc. K934123 C. Description of the Device… | 2000 |
| * | K934123 | Stopcock (One-Port Manifold)Summary page 1…K973128 VACLOK Syringe - Merit Medical System Inc. K994253 STOPCOCK(0ne-port manifold) - Merit Medical System Inc. K934123 C. Description of the Device(s) m”7W NA-200H DISPOSABLE ASPIRATION NEE… | 1993 |
What descends from it? (63)
See all 634 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2021 | Class II | Z-1069-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
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 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K050503 (Olympus Medical Systems Corporation, 2005) has gone furthest, with 28 descendants of its own.
- 2 other devices also cite its predicate K973128.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 4 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This instrument has been designed to be used with the ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023272: Disposable Aspiration Needle NA-200H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023272
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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