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FDA 510(k)

SURFLO Hybria Closed System Safety IV Catheter

K-Number: K252398 · 2025-12-17

ApplicantTerumo Medical Products (Hangzhou) Co., Ltd.
Decision Date2025-12-17
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURFLO Hybria Closed System Safety IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Products (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2025-12-17 under 510(k) number K252398. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURFLO Hybria Closed System Safety IV Catheter?

SURFLO Hybria Closed System Safety IV Catheter is a medical device that received FDA 510(k) clearance on 2025-12-17. The listed applicant is Terumo Medical Products (Hangzhou) Co., Ltd.. The 510(k) number is K252398.

When did SURFLO Hybria Closed System Safety IV Catheter receive FDA 510(k) clearance?

SURFLO Hybria Closed System Safety IV Catheter received FDA 510(k) clearance on 2025-12-17, under 510(k) number K252398.

Who is the listed applicant for SURFLO Hybria Closed System Safety IV Catheter?

The FDA 510(k) record lists Terumo Medical Products (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURFLO Hybria Closed System Safety IV Catheter?

The FDA product code for SURFLO Hybria Closed System Safety IV Catheter is FOZ.

Other records listing Terumo Medical Products (Hangzhou) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252402Midline CatheterK221411Surflo Winged Infusion SetK220934RADIFOCUS Torque Device

Related Devices (Code: FOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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