← Product Code [LHI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI) · K960921 # CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE (K960921) _Codan Medlon, Inc. · LHI · Apr 17, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K960921 ## Device Facts - **Applicant:** Codan Medlon, Inc. - **Product Code:** [LHI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI.md) - **Decision Date:** Apr 17, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The CODAN Spike is designed to be used to transfer medication from a vial to a syringe and from syringe to an IV set. ## Device Story Sterile, nonpyrogenic, multiple-dose vial adapter; facilitates medication transfer between vials, syringes, and IV sets. Incorporates 0.20 µm pressure-resistant hydrophobic filter. Used in clinical settings for drug preparation and administration. Benefits include closed-system-like transfer and filtration of solutions. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Sterile, nonpyrogenic, disposable vial adapter. Features 0.20 µm hydrophobic filter. Materials identical to predicate devices. ## Regulatory Identification An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. ## Special Controls *Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Predicate Devices - Acacia Transfer Pins and Micron Filter ([K901063](/device/K901063.md)) - B. Braun Mini-Spike® Dispensing Pin™ ([K925401](/device/K925401.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K960921 APR 17 1996 ATTACHMENT A 510(k) SUMMARY PAGE 1 of 2 **Submitter's Identification:** CODAN MEDLON, INC. 3325 N. Glenoaks Boulevard Phone: 818-954-9541 Burbank, CA 91504 Fax: 818-848-7045 Contact Person: Aziz Mohabbat Date Summary Prepared: March 1, 1996 **Name of the Device:** CODAN Spike Vial Adapter **Predicate Device Information:** Acacia Transfer Pins and Micron Filter (K901063) B. Braun Mini-Spike® Dispensing Pin™ (K925401) **Device Description:** The Codan Spike is a sterile, nonpyrogenic, multiple dose vial adapter for the preparation and withdrawal of medications and cytotoxic solutions. The Codan Spike contains a 0.20 pm pressure resistant hydrophobic filter that is pressure stable and hydrophobic. **Intended Use:** The CODAN Spike is designed to be used to transfer medication from a vial to a syringe and from syringe to an IV set. **Comparison to Predicate Devices:** The CODAN Spike is substantially equivalent to the Acacia Luer Lock Transfer pin and to the Braun Mini-Spike® Dispensing Pin™. The CODAN Spike and the predicate devices are constructed from the same materials and similar in design and intended uses. Consulting since 1978 {1} m d i ATTACHMENT A 510(k) SUMMARY PAGE 2 OF 2 ## Conclusion: The CODAN Spike is a sterile nonpyrogenic disposable device that is made of identical materials as the legally marketed predicate devices (Acacia Luer Lock Transfer Pin and the Braun Mini-Spike® Dispensing Pin™), with similar indications for use, and is identically processed and sterilized. Consulting since 1978 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K960921](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K960921) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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