Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) → FMG — Stopcock, I.V. Set # FMG · Stopcock, I.V. Set _General Hospital · 21 CFR 880.5440 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG ## Overview - **Product Code:** FMG - **Device Name:** Stopcock, I.V. Set - **Regulation:** [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## 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. ## Classification Rationale 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. ## 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. ## Recent Cleared Devices (20 of 89) Showing 20 most recent of 89 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242255](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K242255.md) | Qitexio® 4-Way Stopcock (QIT014) | Medex | Apr 29, 2025 | SESE | | [K223499](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K223499.md) | Three Way Stop Cock | M/S Romsons International | Jul 21, 2023 | SESE | | [K223175](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K223175.md) | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | Mar 10, 2023 | SESE | | [K211204](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K211204.md) | SafePort(TM) Manifold (or Stopcock) | Elcam Medical Acal | Sep 15, 2022 | SESE | | [K210516](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K210516.md) | Clicky Cross | Yomura Technologies, Inc. | May 16, 2022 | SESE | | [K190539](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K190539.md) | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile | Monumedical, LLC | Oct 22, 2019 | SESE | | [K190489](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K190489.md) | Elcam Stopcocks and Manifolds | Elcam Medical Acal | Apr 23, 2019 | SESE | | [K172266](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K172266.md) | Dynarex Three-Way Stopcock | Dynarex Corporation | Mar 14, 2018 | SESE | | [K141254](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K141254.md) | ELCAM STOPCOCKS AND MANIFOLDS | Elcam Medical Acal | Jul 30, 2014 | SESE | | [K123084](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K123084.md) | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD | Elcam Medical Acal | May 23, 2013 | SESE | | [K130245](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K130245.md) | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | Baxter Healthcare Corp | Mar 1, 2013 | SESE | | [K082110](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K082110.md) | DUAL SYRINGE HOLDER | Surgin Surgical Instrumentation, Inc. | Jun 17, 2009 | SESE | | [K082836](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K082836.md) | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES | Icu Medical, Inc. | Feb 25, 2009 | SESE | | [K082106](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K082106.md) | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | Elcam Medical Acal | Oct 2, 2008 | SESE | | [K080077](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K080077.md) | CLAVE STOPCOCK | Icu Medical, Inc. | Feb 13, 2008 | SESE | | [K071400](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K071400.md) | SMARTSITE STOPCOCK | Cardinal Health, Alaris Products | Dec 14, 2007 | SESE | | [K070143](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K070143.md) | JMS PLANECTA STOPCOCK | Jms North America Corp. | Apr 10, 2007 | SESE | | [K053405](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K053405.md) | BACSTOP | Elcam Medical Acal | May 11, 2006 | SESE | | [K061143](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K061143.md) | ROBERTSITE STOPCOCK | Halkey-Roberts Corp. | May 10, 2006 | SESE | | [K060231](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K060231.md) | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK | Elcam Medical Acal | Apr 13, 2006 | SESE | ## Top Applicants - Elcam Medical Acal — 8 clearances - Icu Medical, Inc. — 5 clearances - Tronomed, Inc. — 5 clearances - American Viggo — 4 clearances - Norton Performance Plastics Corp. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG) **Published by [Innolitics](https://innolitics.com)** — a 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