Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

K-Number: K251340 · 2025-05-29

ApplicantEpic Medical Pte. , Ltd.
Decision Date2025-05-29
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ProSeal™ Bag Spike with Additive Port (423370ST, 423370) is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K251340. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProSeal™ Bag Spike with Additive Port (423370ST, 423370)?

ProSeal™ Bag Spike with Additive Port (423370ST, 423370) is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K251340.

When did ProSeal™ Bag Spike with Additive Port (423370ST, 423370) receive FDA 510(k) clearance?

ProSeal™ Bag Spike with Additive Port (423370ST, 423370) received FDA 510(k) clearance on 2025-05-29, under 510(k) number K251340.

Who is the listed applicant for ProSeal™ Bag Spike with Additive Port (423370ST, 423370)?

The FDA 510(k) record lists Epic Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProSeal™ Bag Spike with Additive Port (423370ST, 423370)?

The FDA product code for ProSeal™ Bag Spike with Additive Port (423370ST, 423370) is ONB.

Other records listing Epic Medical Pte. , 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.

K252987ADRx™ Admixture DeviceK250234SMARTeZ™ Elastomeric Infusion Pump (RS series)K251722ProSeal™ Transfer Injector (421120, 421130, 421140)K251814EZ™ IV Administration SetK252094eZSURE™ Empty Fluid ContainerK243976ZeroClear™ Bag Access (423100)

View all 22 devices →

Related Devices (Code: ONB)

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.

K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte. , Ltd.K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and CompanyK251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare , Ltd.K243976ZeroClear™ Bag Access (423100)Epic Medical Pte. , Ltd.K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte. , Ltd.

Official Source

View on FDA Database →

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

↑