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)

BAG DECANTER

K-Number: K852777 · 1985-08-16

ApplicantAdvance Medical Designs, Inc.
Decision Date1985-08-16
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAG DECANTER is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 1985-08-16 under 510(k) number K852777. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAG DECANTER?

BAG DECANTER is a medical device that received FDA 510(k) clearance on 1985-08-16. The listed applicant is Advance Medical Designs, Inc.. The 510(k) number is K852777.

When did BAG DECANTER receive FDA 510(k) clearance?

BAG DECANTER received FDA 510(k) clearance on 1985-08-16, under 510(k) number K852777.

Who is the listed applicant for BAG DECANTER?

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

What is the FDA product code for BAG DECANTER?

The FDA product code for BAG DECANTER is KPE.

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 Advance Medical Designs, 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.

K223689Disposable Needle Guides and GridsK163050Advance Medical Designs, Inc. Sterile Ultrasound GelK053495EQUIPMENT SLUSH DRAPEK011265ULTRASOUND TRANSDUCER COVERK012168ADVANCE MEDICAL DESIGNS FLUID POUCHK011422SURGICAL DRAPES

View all 32 devices →

Related Devices (Code: KPE)

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.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic 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.

↑