← Product Code [KTI](/productcode/KTI) · K251478 # ClearTip TBNA Type (K251478) _Finemedix Co., Ltd. · KTI · Apr 16, 2026 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K251478 ## Device Facts - **Applicant:** Finemedix Co., Ltd. - **Product Code:** [KTI](/productcode/KTI.md) - **Decision Date:** Apr 16, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4680 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat ## Indications for Use The ClearTip TBNA Type is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree. ## Device Story ClearTip TBNA Type is a manually operated endoscopic instrument for obtaining tissue specimens from the tracheobronchial tree. The device consists of a handle unit, insertion part, syringe, stopcock, and connector. It is designed to pass through the working channel of an endoscope. During clinical use, the physician operates the device to perform fine needle aspiration of submucosal or extraluminal lesions under ultrasonic guidance. The device is supplied sterile for single-patient use. By enabling targeted tissue sampling, it assists in the diagnosis of lesions within the tracheobronchial tree. ## Clinical Evidence No clinical data. Substantial equivalence is supported by non-clinical bench testing, including appearance, dimensions, operability, elasticity, flexural strength, pull-out, tensile force, insertion/withdrawal force, needle extraction/retraction, and needle slider performance. ## Technological Characteristics Manual endoscopic instrument; materials include PEEK, Nitinol, and PTFE. Dimensions: 19G/22G needles; sheath lengths 746.5-774.5 mm. Compatible with minimum 2.2 mm accessory channels. Sterilized via Ethylene Oxide (EO). Single-use, non-powered device. ## Regulatory Identification A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier. ## Predicate Devices - Single Use Aspiration Needle ([K190239](/device/K190239.md)) ## Reference Devices - ClearTip ([K231267](/device/K231267.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION April 16, 2026 FINEMEDIX Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman STE 160 Irvine, California 92612 Re: K251478 Trade/Device Name: ClearTip TBNA Type Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: March 18, 2026 Received: March 18, 2026 Dear Priscilla Chung: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251478 - Priscilla Chung Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K251478 - Priscilla Chung Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Ethan L. Nyberg -S Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251478 | | | Device Name ClearTip TBNA Type | | | Indications for Use (Describe) | | | The ClearTip TBNA Type is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} # 510(K) SUMMARY (K251478) Apr 15, 2026 ## 1. Submitted by: FINEMEDIX Co., Ltd. 140-9, Yuram-ro, Dong-gu, Daegu, 41059 Republic of Korea Tel: 82-53-741-8388, Fax: 82-53-741-8168 ## 2. US Agent/ Official Correspondent: Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine, CA 92612 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com ## 3. Device Name: - Trade Name: ClearTip TBNA Type - Classification: Class II - Classification Name: Bronchoscope (Flexible Or Rigid) And Accessories - Product Code: KTI - Regulation Number: 874.4680 - Review Panel: Ear Nose & Throat ## 4. Predicate Devices: Primary Predicate Device - Single Use Aspiration Needle (K190239) by Olympus Medical Systems Corp. Reference Device - ClearTip (K231267) by FINEMEDIX Co., Ltd. Page 1 of 4 {5} Page 2 of 4 # 5 Device Description: The ClearTip TBNA Type is a manually operated endoscopic instrument intended to obtain tissue specimens of tracheobronchial tree. The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. This device passes through a working channel of an endoscope, and the average contact time with the submucosal or external lesions of a tracheobronchial tree is less than 1 hour. This device is supplied sterile for single-patient use and shall not be reused or re-sterilized. # 6 Indications for Use Statement The ClearTip TBNA Type is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree. # 7 Substantial Equivalence Discussion: ## 7.1. Comparison Chart | | Subject Device | Primary Predicate | Reference Device | Comparison | | --- | --- | --- | --- | --- | | Manufacturer | FINEMEDIX Co., Ltd. | Olympus Medical Systems Corp. | FINEMEDIX Co., Ltd. | | | Device Name | ClearTip TBNA Type | Single Use Aspiration Needle | ClearTip | | | 510(k) Number | K251478 | K190239 | K231267 | | | Device Classification Name | Bronchoscope (Flexible Or Rigid) And Accessories | Bronchoscope (Flexible Or Rigid) And Accessories | Gastroenterology- urology Biopsy instrument | | | Product Code | KTI | KTI | FCG | | | Regulation Number | 21 CFR 874.4680 | 21 CFR 874.4680 | 21 CFR 876.1075 | | | Indications for Use | The ClearTip TBNA Type is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree. | This instrument has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the Tracheobronchial Tree. | The ClearTip is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum). | Similar | | Handle Design | | | | Slightly different | | Needle Gauge | 19, 22 Gauge | 25 Gauge | 22 Gauge | Slightly different | | Needle length Adjustment | 0~5 cm | 2~4 cm | 0~5 cm | Similar | {6} | range | | | | | | --- | --- | --- | --- | --- | | Sheath length | 746.5 mm, 754.5 mm, 774.5 mm | 700 mm | 738.5 mm | Slightly different | | Total length of the needle | 915mm, 935mm, 955mm | - | 999mm, 1,005mm. | Slightly different | | Patient Contacting Materials Outer Sheath | PEEK, Nitinol, PTFE | Polytetrafluoroethylene, Stainless Steel, Nickel Titanium | PEEK, Nitinol, PTFE | Similar | | Sheath length Adjustment range | 0~3cm | 0~2cm | 0~3cm | Similar | | Accessory Channel Diameter | Minimum Accessory Channel Diameter (2.2 mm) | Minimum Accessory Channel Diameter (2.0 mm) | Minimum Accessory Channel Diameter (2.0 mm) | Similar | | Use with a Syringe and stopcock | Yes | Yes | Yes | Similar | | Principle of Operation | Manual (sampling using aspiration) | Manual (sampling using aspiration) | Manual (sampling using aspiration) | Similar | | Shelf life | 3 Years | 3 Years | 3 Years | Similar | | Sterility | Ethylene oxide(EO) | Ethylene oxide(EO) | Ethylene oxide(EO) | Similar | | Single use | Yes | Yes | Yes | Similar | ## 7.2. Substantial Equivalence Discussion The reference device (unmodified device) manufactured by our company covers the indication for use as the subject device. The differences between the subject device and the unmodified device are limited to the handle shape, the addition of one additional needle gauge option (19 gauge), the sheath length, and the total needle length. The modified handle design is similar to that of the primary predicate device, K190239. To evaluate whether these differences affect the safety or effectiveness of the subject device, comparative performance testing was conducted between the subject device and the predicate device. The testing addressed the modified dimensional characteristics. The results demonstrated that the subject device performs comparably to the unmodified device and meets the same acceptance criteria. Based on the test results, we determine that the subject device is substantially equivalent to the predicate device. ## 8. Non-clinical Tests The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices. - Appearance {7} - Dimensions - Operability - Elasticity - Flexural strength - Pull out - Tensile force tests - Insertion and Withdrawal Force - Needle Extraction/Retraction - Needle Slider Performance 9. Conclusion: Based on the information provided herein and the test results, we conclude that the subject device is substantially equivalent to its predicate device. Page 4 of 4 --- **Source:** [https://fda.innolitics.com/device/K251478](https://fda.innolitics.com/device/K251478) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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