510(k) · Cleared
Recalled · Class II · 2021Single Use Aspiration Needle NA-201SX-4022
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · FCG Biopsy Needle
Cleared on May 12, 2005 as substantially equivalent to K042140 (Olympus Corporation, 2004) and 3 other predicates after a 73-day review. Its family tree reaches back 8 generations to 1989. 2 of the 83 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it. It has been recalled 5 times.
- Decided
- May 12, 2005
- Review
- 73 days
- Class
- Class II
- Product code
- FCG
- Recalls
- 5
- Predicates
- 4
Its longest line of descent runs back 8 generations to K894632 (1989). 54 ancestors in all, the oldest K812810 (1981). 28 later devices descend from it, 6 citing it directly. 2 of the 83 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 7 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 6 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 5 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 4 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 3 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 2 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 1 generation backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- This deviceK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005
- Descendant · cites it directly · 8 of its ownK093195 Echotip Ultra Endobronchial High Definition Ultasound Needle, Model…Cook Ireland, Ltd. · 2010
- Descendant · 2 generations on · 7 of its ownK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
- Descendant · cites it directly · 7 of its ownK142909 Flexible 19G EBUS NeedleSpiration, Inc. · 2015
- Descendant · 2 generations on · 6 of its ownK152922 ViziShot FLEXSpiration, Inc. · 2016
- Descendant · 3 generations on · 5 of its ownK163469 ViziShot 2 FLEXOlympus Surgical Technologies America · 2017
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd. · 2010 · cites it directly8descendants
- K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd. · 2016 · 2 generations on7descendants
- K142909Flexible 19G EBUS NeedleSpiration, Inc. · 2015 · cites it directly7descendants
- K152922ViziShot FLEXSpiration, Inc. · 2016 · 2 generations on6descendants
- K163469ViziShot 2 FLEXOlympus Surgical Technologies America · 2017 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −7 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −6 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −5 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −4 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −3 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −2 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| −1 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| 0 (this device) | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | — |
| +1 | K093195 | Echotip Ultra Endobronchial High Definition Ultasound Needle, Model… | Cook Ireland, Ltd. | 2010 | — |
| +2 | K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore… | Cook Ireland, Ltd. | 2016 | — |
| +1 | K142909 | Flexible 19G EBUS Needle | Spiration, Inc. | 2015 | — |
| +2 | K152922 | ViziShot FLEX | Spiration, Inc. | 2016 | — |
| +3 | K163469 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 1 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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.
2 devices in this family have 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? (4)
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 |
|---|---|---|---|
| * | K042140 | Olympus BF Type UC160-OL8Summary page 2…Product Device Name 510(k) # Manufacturer Class Code EVIS EXERA Ultrasonic #K042140 Olympus Corporation ]] KOG Bronchofibervideoscope Olympus BF Type UC160F-OL8, OLYMPUS EU-C60 EUS… | 2004 |
| * | K994253 | Vaclok SyringeSummary page 2…Bronchofibervideoscope Olympus BF Type UC160F-OL8, OLYMPUS EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center VACLOK Syringe #K994253 Merit Medical System Inc. II FMF STOPCOCK(One-port manifold) #K934123 Merit Medical System Inc.… | 2000 |
| * | K934123 | Stopcock (One-Port Manifold)Summary page 2…Endoscopic Ultrasound Center VACLOK Syringe #K994253 Merit Medical System Inc. II FMF STOPCOCK(One-port manifold) #K934123 Merit Medical System Inc. ]l DTL Disposable Aspiration Needle #K023272 Olympus Corporation… | 1993 |
| * | K023272 | Disposable Aspiration Needle NA-200HSummary page 2…cal System Inc. II FMF STOPCOCK(One-port manifold) #K934123 Merit Medical System Inc. ]l DTL Disposable Aspiration Needle #K023272 Olympus Corporation ]] FCG NA-200H D. DESCRIPTION OF THE DEVICE The NA-201SX-4022 Single Use Aspira… | 2002 |
What descends from it? (28)
See all 286 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093195 | Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-O | 2010 | 8 |
| K142909 | Flexible 19G EBUS Needle | 2015 | 7 |
| K151315 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | 2015 | 3 |
| K091257 | Medi-Globe Sonotip II Ebus-Tbna Needle System | 2009 | 3 |
| K160098 | Single Use Aspiration Needle NA-U401SX | 2016 | 1 |
| K151895 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | 2015 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2021 | Class II | Z-1060-2021 | 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. |
| Jan 4, 2021 | Class II | Z-1062-2021 | 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. |
| Jan 4, 2021 | Class II | Z-1059-2021 | 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. |
| Jan 4, 2021 | Class II | Z-1061-2021 | 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. |
| Aug 25, 2011 | Not classified | Z-0029-2012 | Device Design | Firm has received complaints from users of the ability to wipe material from the needle's stylet and the presence of material in patient cytology samples obtained by the needle following endobronchial ultrasound fine needle aspiration of… |
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 54 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K093195 (Cook Ireland, Ltd., 2010) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K042140.
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 ultrasonic endoscopes for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
Do not use this instrument for any purpose other than its intended use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050503 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050503: Single Use Aspiration Needle NA-201SX-4022.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050503
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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