Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FCG — Predicate Candidate Screening
133 FDA 510(k) clearances under this product code; the 50 most recent screened below.
82 daysmedian FDA review time
243 days90th percentile
133clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | 2025-10-24 | 64 | 0 |
| K250994 | ClearTip FNA and FNB Types | Finemedix Co., Ltd. | 2025-08-21 | 142 | 0 |
| K241209 | EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) | Cook Ireland, Ltd. | 2024-07-29 | 90 | 0 |
| K231422 | Precision GI | Limaca Medical, Ltd. | 2023-08-28 | 103 | 0 |
| K231267 | ClearTip | Finemedix Co., Ltd. | 2023-06-30 | 59 | 0 |
| K230909 | EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | 2023-05-30 | 60 | 0 |
| K212423 | EndoDrill® Model X | Bibbinstruments AB | 2023-03-29 | 602 | 0 |
| K212819 | Disposable Biopsy Refill Needle | Suzhou Leapmed Healthcare Corporation | 2022-07-06 | 306 | 0 |
| K212822 | Disposable Coaxial Biopsy Needle | Suzhou Leapmed Healthcare Corporation | 2022-07-06 | 306 | 0 |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore | Cook Ireland, Ltd. | 2021-05-20 | 90 | 1 |
| K191472 | Biopsy Needle | Ushare Medical, Inc. | 2020-01-29 | 240 | 0 |
| K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Nee | Apriomed AB | 2018-12-18 | 169 | 0 |
| K180668 | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | Olympus Medical Systems Corp. | 2018-11-15 | 246 | 0 |
| K180363 | Clear-Tip EUS-FNA | Finemedix Co., Ltd. | 2018-11-01 | 265 | 0 |
| K181994 | Single Use Aspiration Needle NA-U201H | Olympus Medical Systems Corp. | 2018-10-31 | 97 | 0 |
| K180449 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | 2018-06-08 | 108 | 0 |
| K180037 | Beacon EUS Access System | Covidien, LLC | 2018-04-26 | 111 | 2 |
| K171956 | Sterile Endoscope Biopsy Sampling Needle | Changzhou Detain Medical Devices Co., Ltd. | 2017-12-12 | 166 | 0 |
| K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultraso | Wilson-Cook Medical, Inc. | 2017-08-04 | 65 | 0 |
| K160890 | Howell Biliary Introducer Needle | Wilson-Cook Medical, Inc. | 2017-06-14 | 440 | 0 |
| K160423 | Perineologic Access Needle | Corbin Clinical Resources, LLC | 2016-09-02 | 199 | 0 |
| K160098 | Single Use Aspiration Needle NA-U401SX | Olympus Medical Systems Corp. | 2016-03-22 | 63 | 2 |
| K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needl | Cook Ireland, Ltd. | 2016-03-21 | 49 | 0 |
| K151738 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | 2015-11-20 | 147 | 0 |
| K151895 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Asp | Boston Scientific Corporation | 2015-10-22 | 104 | 0 |
| K151373 | Corvocet Coaxial Introducer | Merit Medical Systems, Inc. | 2015-08-07 | 78 | 1 |
| K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Need | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2015-05-01 | 29 | 0 |
| K142688 | Echotip Procore HD Ultrasound Biopsy Needle | Cook Ireland, Ltd. | 2014-12-19 | 88 | 0 |
| K131925 | HS NOTA | H.S. Hospital Services S.P.A. | 2014-10-10 | 471 | 0 |
| K141894 | SHARKCORE FINE NEEDLE BIOPSY SYSTEM | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2014-10-06 | 84 | 0 |
| K133763 | SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM | Medi-Globe Corporation | 2014-05-15 | 155 | 0 |
| K140137 | SAFETY BIOPSY NEEDLE SYSTEM | Pfm Medical, Inc. | 2014-03-25 | 62 | 0 |
| K133008 | BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEED | Beacon Endoscopic | 2013-11-20 | 56 | 0 |
| K103694 | TISSUE SAMPLING NEEDLE | United States Endoscopy Group, Inc. | 2011-07-27 | 222 | 0 |
| K103668 | BNX FINE NEEDLE ASPIRATION SYSTEM | Boston Endoscopic Engineering | 2010-12-30 | 14 | 5 |
| K100712 | RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | Boston Scientific Corporation | 2010-03-30 | 18 | 5 |
| K093195 | ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE | Cook Ireland, Ltd. | 2010-01-21 | 104 | 0 |
| K092359 | ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MOD | Cook Ireland, Ltd. | 2009-11-02 | 90 | 1 |
| K091257 | MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM | Medi-Globe Corporation | 2009-05-08 | 9 | 0 |
| K083802 | SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01- | Medi-Globe Corporation | 2009-03-20 | 88 | 0 |
| K083330 | ECHOTIP ULTRA ULTRASOUND NEEDLE | Cook Endoscopy | 2009-02-06 | 86 | 0 |
| K081323 | BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOP | B-K Medical Aps | 2008-07-22 | 71 | 0 |
| K073399 | TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE | Envisioneering, LLC | 2007-12-21 | 17 | 0 |
| K062979 | THYROSAMPLER | Acd Medical Innovation Corp. | 2007-05-30 | 243 | 0 |
| K070179 | TROKABONE, TROKABONE STERNAL | PAJUNK GmbH Medizintechnologie | 2007-03-07 | 47 | 0 |
| K070129 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | Medi-Globe Corporation | 2007-01-31 | 15 | 0 |
| K051506 | MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SP | Sterylab S.R.L. | 2005-07-27 | 50 | 0 |
| K050135 | K-C HEMOSTATIC BIOPSY SYSTEM | Bioengineering Consultants , Ltd. | 2005-07-13 | 173 | 0 |
| K051247 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | Medi-Globe Corp. | 2005-06-16 | 31 | 0 |
| K050503 | SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 | Olympus Medical Systems Corporation | 2005-05-12 | 73 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda