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)

OMNIMED IV SOLUTION ADMINISTRATION SET

K-Number: K850112 · 1985-02-22

ApplicantOmni Intl., Inc.
Decision Date1985-02-22
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OMNIMED IV SOLUTION ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Omni Intl., Inc.. It received FDA 510(k) clearance on 1985-02-22 under 510(k) number K850112. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIMED IV SOLUTION ADMINISTRATION SET?

OMNIMED IV SOLUTION ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 1985-02-22. The listed applicant is Omni Intl., Inc.. The 510(k) number is K850112.

When did OMNIMED IV SOLUTION ADMINISTRATION SET receive FDA 510(k) clearance?

OMNIMED IV SOLUTION ADMINISTRATION SET received FDA 510(k) clearance on 1985-02-22, under 510(k) number K850112.

Who is the listed applicant for OMNIMED IV SOLUTION ADMINISTRATION SET?

The FDA 510(k) record lists Omni Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNIMED IV SOLUTION ADMINISTRATION SET?

The FDA product code for OMNIMED IV SOLUTION ADMINISTRATION SET is FPA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Omni Intl., Inc. 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.

K984066OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIMK984064OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREEK853255OMNIMED I.V. SOLUTION ADMIN. SETK851938OMNIMED SURGICAL GOWNK851654OMNIMED CLAMPK851734OMNIMED SUPERIOR TRANSDUCER PROTECTOR

View all 12 devices →

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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.

↑