BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

K251019 · Bioteque Corporation · FGE · Dec 22, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K251019
• Device Name: BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
• Applicant: Bioteque Corporation
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Dec 22, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The catheter is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.

Device Story

Percutaneous drainage catheter set used for draining abscesses, cysts, gall bladders, and urinary fluids. Device consists of TPU catheter with hydrophilic coating, radiopaque material, and distal pigtail or mini-pigtail configuration. Operated by clinicians in clinical settings. Input involves manual insertion via Seldinger or one-step technique; catheter facilitates fluid drainage through distal holes. Output is the drainage of target fluids. Benefits include minimally invasive fluid management. Device includes various accessories like stiffening cannulas, trocar needles, and suture wires.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including sterilization validation (ISO 11135), shelf-life testing (ISO 20697, ISO 80369-7/20), and comprehensive biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and implantation).

Technological Characteristics

Catheter material: TPU; Coating: Hydromer AQUA 65JL; Distal configuration: Pigtail/mini-pigtail; Radiopaque; Sterilization: Ethylene Oxide; Sizes: 5-16 Fr; Lengths: 20-50 cm; Accessories: Stiffening cannulas, trocar needles, suture wires, curve straighteners.

Indications for Use

Indicated for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and other fluids in adults; clinicians to select appropriate size for pediatric use.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• BIOTEQ Drainage Catheter Set (Seldinger Type) (K210419)
• BIOTEQ Drainage Catheter Set (One Step Type) (K200103)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 22, 2025

Bioteque Corporation
Stella Hsu
RA Specialist
5F-6, No. 23, Sec.1, Chang'an E. Rd.,
Zhongshan Dist
Taipei, 104
Taiwan

Re: K251019
Trade/Device Name: BIOTEQ Drainage Catheter Set: BT-PD1-SERIES and BT-PDS-SERIES
Regulation Number: 21 CFR 876.5010
Regulation Name: Biliary Catheter And Accessories
Regulatory Class: Class II
Product Code: FGE, LJE, GBO
Dated: November 20, 2025
Received: November 20, 2025

Dear Stella Hsu:

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

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K251019 - Stella Hsu
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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 systems (QS) regulation (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-

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K251019 - Stella Hsu
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

ANTHONY LEE -S

Anthony Lee, Ph.D., MBA
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251019 | |
| Device Name BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | |
| Indications for Use (Describe) The catheter is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids. | |
| 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 [e-mail] | |
| "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." | |

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K251019 page 1 of 10

Bioteque Corporation
BIOTEQ Drainage Catheter Set

# 510(k) Summary

1. Type of submission: Traditional

Date of Summary: December 19, 2025

2. Submitter: Bioteque Corporation

| Address | 5F-6, No. 23, Sec. 1, Chang’an E. Rd., Zhongshan Dist. Taipei City, 104 Taiwan |
| --- | --- |
| Phone | [phone] ext. 1348 |
| Fax | [phone] |
| Contact | Stella Hsu ([e-mail]) |

3. Identification of the Device:

Device Name: BIOTEQ Drainage Catheter Set

Classification Product Code: FGE

Subsequent Product Code: LJE, GBO

Regulation Number: 876.5010

Regulation Description: Biliary catheter and accessories; Introduction/drainage catheter and accessories.

Review Panel: Gastroenterology/Urology; General & Plastic Surgery

Device Class: II

Basis for the Submission: New device

4. Identification of the Predicate Device I:

Predicate Device Name: BIOTEQ Drainage Catheter Set (Seldinger Type) Model name: BT-PDS-series

Manufacturer: Bioteque Corporation

Classification Product Code: FGE

Subsequent Product Code: LJE, GBO

Regulation number: 876.5010

Device Class: II

510(k) number: K210419

5. Identification of the Predicate Device II:

Predicate Device Name: BIOTEQ Drainage Catheter Set (One Step Type) Model name: BT-PD1-series

Manufacturer: BIOTEQUE CORPORATION

Classification Product Code: FGE

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K251019 page 2 of 10

Bioteque Corporation
BIOTEQ Drainage Catheter Set

Subsequent Product Code: LJE, GBO

Regulation number: 876.5010

Device Class: II

510(k) number: K200103

## 6. Device Description

The BT-PD1-SERIES-G / BT-PD1-SERIES(MN)-G / BT-PD1-SERIES-G(+FSC) / BT-PDS-SERIES-G / BT-PDS-SERIES(MN)-G / BT-PDS-SERIES(B)-RB-G Percutaneous Drainage Catheter with hydrophilic coating is a percutaneous drainage catheter used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a pigtail or mini-pigtail close loop and drainage holes.

## 7. Indications for Use

The catheter is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.

## 8. Performance Data - Non-clinical Testing

The following performance data were provided in support of the substantial equivalence determination.

(1) Sterilization validation

The ethylene oxide (EO) sterilization and related validation testing were conducted in accordance and complied with ISO 11135, ISO 10993-7, ISO 11737-1, ISO 11737-2, USP, and EN 556-1.

(2) Shelf-life

The shelf-life testing was conducted and complied with ISO 20697, ISO 80369-7, 80369-20, ASTM F1140/F1140M, ISO11070, ISO9626, ISO 2859-1.

(3) Biocompatibility

The biocompatibility evaluation was conducted, and the endpoint testing included the following tests:

- In vitro Cytotoxicity test
- Skin Sensitization Study in Guinea Pigs
- Intracutaneous Irritation Study in White Rabbits
- Acute Systemic Toxicity Study in Mice

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K251019 page 3 of 10

Bioteque Corporation
BIOTEQ Drainage Catheter Set

- Pyrogen test in white rabbit
- A Dual Route sub chronic systemic toxicity study in rats
- Salmonella reverse mutation test
- In vitro mammalian chromosomal aberration test
- Rodent Micronucleus Test in Peripheral Blood
- Muscle Implantation study in white rabbits

(4) Performance

The performance testing was conducted and complied with ISO 20697, ISO 80369-7, ISO 80369-20.

9. Performance Data - Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

10. Substantial equivalence comparison

BIOTEQ Drainage Catheter Set submitted in 510(k) files is substantially equivalent in intended use, safety and performance to the FDA cleared BIOTEQ Drainage Catheter Set (Seldinger Type) (K210419) and BIOTEQ Drainage Catheter Set (One Step Type) (K200103). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

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K251019 page 4 of 10

Bioteque Corporation

BIOTEQ Drainage Catheter Set

| Item | Subject device | Predicate device | Substantial equivalence determination |
| --- | --- | --- | --- |
| Proprietary name | BIOTEQ Drainage Catheter Set | BIOTEQ Drainage Catheter Set | |
| Series | BT-PDS-series-G | BT-PDS-series | - |
| 510(k) No. | K251019 | K210419 | - |
| Intended Use | The BIOTEQ Drainage Catheter Set (Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. | The BIOTEQ Drainage Catheter Set (Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. | Equivalent Both the devices are used for percutaneous drainage in gastroenterology and urology. |
| Type of Use | Prescription Use | Prescription Use | Same |
| Intended patient population | Adults and recommending clinician should choose an appropriate catheter size for pediatric use. | Adults and recommending clinician should choose an appropriate catheter size for pediatric use | Same |
| Catheter Shaft Material | TPU | TPU | Same |
| Coating Material | Hydromer AQUA 65JL | Hydromer AQUA 65JL | Same |
| Catheter color | Green | Blue | Different |
| Distal Configuration | String Locking Pigtail, Non-String Locking Pigtail | String Locking Pigtail, Non-String Locking Pigtail | Same |

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Bioteque Corporation

BIOTEQ Drainage Catheter Set

K251019 page 5 of 10

| Item | Subject device | Predicate device | Substantial equivalence determination |
| --- | --- | --- | --- |
| Proprietary name | BIOTEQ Drainage Catheter Set | BIOTEQ Drainage Catheter Set | |
| Distal Shape | Pigtail, Mini-closed Pigtail | Pigtail, Closed-Pigtail | Equivalent
Both the devices have pigtail shape. |
| Distal Hydrophilic Coating | Yes | Yes | Same |
| Shaft Depth Printing Markers | Yes | Yes | Same |
| Proximal Hub Assembly | Hub (for String Lock Pigtail), F.L.L. Adapter | Hub (for String Lock Pigtail), F.L.L. Adapter | Same |
| Size | 5 Fr (Non-String Lock), 6, 7, 8, 10, 12, 14, 16 Fr | 8, 10, 12, 14 Fr | Different but do not raise new issues of SE |
| Usable Length | 20, 25, 30, 35, 40, 45, 50 cm | 40, 45, 50 cm | Different but do not raise new issues of SE |
| Included Insert Accessory | Metal Stiffening Cannula
Flexible (plastic) Stiffening Cannula
Wire cap, Suture Wire,
Curve Straightener, Radiopaque band | Metal Stiffening Cannula
Flexible (plastic) Stiffening Cannula
Wire cap, Suture Wire,
Curve Straightener, Radiopaque band | Equivalent
The accessory of subject device is equivalent to the predicate device |
| Packaging | Tyvek/Mylar (PET/LDPE) pouch | Tyvek/Mylar (PET/LDPE) pouch | Same |

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K251019 page 6 of 10

Bioteque Corporation

BIOTEQ Drainage Catheter Set

| Item | Subject device | Predicate device | Substantial equivalence determination |
| --- | --- | --- | --- |
| Proprietary name | BIOTEQ Drainage Catheter Set | BIOTEQ Drainage Catheter Set | |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |

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K251019 page 7 of 10

Bioteque Corporation

BIOTEQ Drainage Catheter Set

| Item | Subject device | Predicate device | Substantial equivalence determination |
| --- | --- | --- | --- |
| Proprietary name | BIOTEQ Drainage Catheter Set (One step Type) | BIOTEQ Drainage Catheter Set (One Step Type) | |
| Series | BT-PD1-series-G | BT-PD1-series | - |
| 510(k) No. | K251019 | K200103 | - |
| Intended Use | The BIOTEQ Drainage Catheter Set (One step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. | The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids. | Equivalent
Both the devices are used for percutaneous drainage in gastroenterology and urology. |
| Type of Use | Prescription Use | Prescription Use | Same |
| Intended patient population | Adults and recommending clinician should choose an appropriate catheter size for pediatric use | Adults and recommending clinician should choose an appropriate catheter size for pediatric use | Same |
| Catheter Shaft Material | TPU | TPU | Same |
| Coating Material | Hydromer AQUA 65JL | Hydromer AQUA 65JL | Same |
| Catheter color | Green | Blue | Different |
| Distal Configuration | String Locking Pigtail, Non-String Locking Pigtail | String Locking Pigtail, Non-String Locking Pigtail | Same |

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K251019 page 8 of 10

Bioteque Corporation

BIOTEQ Drainage Catheter Set

| Item | Subject device | Predicate device | Substantial equivalence determination |
| --- | --- | --- | --- |
| Proprietary name | BIOTEQ Drainage Catheter Set (One step Type) | BIOTEQ Drainage Catheter Set (One Step Type) | |
| Distal Shape | Pigtail, Mini-closed Pigtail | Pigtail, Closed-Pigtail, Mini-Pigtail, Mini-closed Pigtail, J shape | Equivalent
All the devices have pigtail and mini-closed pigtail shape. |
| Distal Hydrophilic Coating | Yes | Yes | Same |
| Shaft Depth Printing Markers | Yes | Yes | Same |
| Proximal Hub Assembly | Hub (for String Lock Pigtail), F.L.L. Adapter | Hub (for String Lock Pigtail), F.L.L. Adapter | Same |
| Size | 5 Fr (Non-String Lock), 6, 7, 8, 10, 12, 14, 16 Fr | 5 Fr (Non-String Lock), 6, 7, 8, 10, 12, 14, 16 Fr | Same |
| Useable Length | 20, 25, 30, 35, 40, 45, 50 cm | 20, 25, 30, 35, 40, 45, 50 cm | Same |
| Included Insert Accessory | Trocar needle, Trocar stylet Flexible (plastic) Stiffening Cannula Wire cap, Suture Wire, Curve Straightener | Trocar needle, Trocar stylet Flexible (plastic) Stiffening Cannula Wire cap, Suture Wire, Curve Straightener | Same |
| Packaging | Tyvek/Mylar (PET/LDPE) pouch | Tyvek/Mylar (PET/LDPE) pouch | Same |

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K251019 page 9 of 10

Bioteque Corporation

BIOTEQ Drainage Catheter Set

| Item | Subject device | Predicate device | Substantial equivalence determination |
| --- | --- | --- | --- |
| Proprietary name | BIOTEQ Drainage Catheter Set (One step Type) | BIOTEQ Drainage Catheter Set (One Step Type) | |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |

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K251019 page 1 of 10

Bioteque Corporation
BIOTEQ Drainage Catheter Set

## 11. Conclusion

The data supports the safety and performance of the subject device and demonstrates that the subject device is substantially equivalent to the predicate device.