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)

LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE

K-Number: K942271 · 1995-07-12

ApplicantLevel 1 Technologies, Inc.
Decision Date1995-07-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE is the device name listed in this FDA 510(k) record. The listed applicant is Level 1 Technologies, Inc.. It received FDA 510(k) clearance on 1995-07-12 under 510(k) number K942271. 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 LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE?

LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE is a medical device that received FDA 510(k) clearance on 1995-07-12. The listed applicant is Level 1 Technologies, Inc.. The 510(k) number is K942271.

When did LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE receive FDA 510(k) clearance?

LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE received FDA 510(k) clearance on 1995-07-12, under 510(k) number K942271.

Who is the listed applicant for LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE?

The FDA 510(k) record lists Level 1 Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE?

The FDA product code for LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE 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 Level 1 Technologies, 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.

K942844LEVEL 1 BLOOD STREAM RECOVERY SYSTEMK936223PRESSURE IRRIGATING SYSTEMK911383HOTLINE FLUID WARMERK873435LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET

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.

↑