FMG · Stopcock, I.V. Set
General Hospital · 21 CFR 880.5440 · Class 2
Overview
| Product Code | FMG |
|---|---|
| Device Name | Stopcock, I.V. Set |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 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 | Qitexio® 4-Way Stopcock (QIT014) | Medex | Apr 29, 2025 | SESE |
| K223499 | Three Way Stop Cock | M/S Romsons International | Jul 21, 2023 | SESE |
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | Mar 10, 2023 | SESE |
| K211204 | SafePort(TM) Manifold (or Stopcock) | Elcam Medical Acal | Sep 15, 2022 | SESE |
| K210516 | Clicky Cross | Yomura Technologies, Inc. | May 16, 2022 | SESE |
| K190539 | 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 | Elcam Stopcocks and Manifolds | Elcam Medical Acal | Apr 23, 2019 | SESE |
| K172266 | Dynarex Three-Way Stopcock | Dynarex Corporation | Mar 14, 2018 | SESE |
| K141254 | ELCAM STOPCOCKS AND MANIFOLDS | Elcam Medical Acal | Jul 30, 2014 | SESE |
| K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD | Elcam Medical Acal | May 23, 2013 | SESE |
| K130245 | 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 | DUAL SYRINGE HOLDER | Surgin Surgical Instrumentation, Inc. | Jun 17, 2009 | SESE |
| K082836 | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES | Icu Medical, Inc. | Feb 25, 2009 | SESE |
| K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | Elcam Medical Acal | Oct 2, 2008 | SESE |
| K080077 | CLAVE STOPCOCK | Icu Medical, Inc. | Feb 13, 2008 | SESE |
| K071400 | SMARTSITE STOPCOCK | Cardinal Health, Alaris Products | Dec 14, 2007 | SESE |
| K070143 | JMS PLANECTA STOPCOCK | Jms North America Corp. | Apr 10, 2007 | SESE |
| K053405 | BACSTOP | Elcam Medical Acal | May 11, 2006 | SESE |
| K061143 | ROBERTSITE STOPCOCK | Halkey-Roberts Corp. | May 10, 2006 | SESE |
| K060231 | 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
