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 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725) → LDR — Controller, Infusion, Intravascular, Electronic # LDR · Controller, Infusion, Intravascular, Electronic _General Hospital · 21 CFR 880.5725 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR ## Overview - **Product Code:** LDR - **Device Name:** Controller, Infusion, Intravascular, Electronic - **Regulation:** [21 CFR 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 60) Showing 20 most recent of 60 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242693](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K242693.md) | DEKA Infusion System, DEKA Administration Set | Deka Research and Development Corporation | Oct 7, 2024 | SESE | | [K232316](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K232316.md) | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | Mar 1, 2024 | SESE | | [K153760](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K153760.md) | Volumetric Infusion Controller | DEKA Research & Development | Oct 3, 2016 | SESE | | [K963136](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K963136.md) | PACER MODEL 100 INFUSION CONTROLLER | Health Watch, Inc. | Oct 10, 1997 | SESE | | [K971865](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K971865.md) | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P | Alexander Mfg. Co. | Jul 3, 1997 | SESE | | [K971826](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K971826.md) | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 | Alexander Mfg. Co. | Jul 3, 1997 | SESE | | [K934543](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K934543.md) | UNIVERSAL CONTROLLER, MODEL 100 | Metamed, Inc. | Mar 29, 1994 | SESE | | [K935236](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K935236.md) | FLOW CONTROLLING EXTENSION SET | Block Medical, Inc. | Feb 24, 1994 | SESE | | [K905498](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K905498.md) | STAT 2 IV PUMPETTE | The Master Medical Corp. | Apr 16, 1991 | SESE | | [K905497](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K905497.md) | MASTER FLOW I.V. PUMPETTE | The Master Medical Corp. | Apr 16, 1991 | SESE | | [K896907](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K896907.md) | 3M IV FLOW REGULATOR | 3M Company | Feb 26, 1990 | SESE | | [K894111](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K894111.md) | VARI-SET | Sonex Medical | Sep 28, 1989 | SESE | | [K894487](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K894487.md) | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ | Y | Sep 27, 1989 | SESE | | [K893487](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K893487.md) | LIFECARE 75 CONTROLLER | Abbott Laboratories | Jul 28, 1989 | SESE | | [K884307](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K884307.md) | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262 | Y | Nov 1, 1988 | SESE | | [K882167](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K882167.md) | IVY COMMANDER, MODEL 600 | Ivy Medical, Inc. | Sep 23, 1988 | SESE | | [K880006](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K880006.md) | STA-SET I.V. FLOW REGULATOR | Controlled Flow , Ltd. | Mar 24, 1988 | SESE | | [K874916](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K874916.md) | TECHNICON CHEM 1(TM) SYSTEM | Technicon Instruments Corp. | Mar 3, 1988 | SESE | | [K874481](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K874481.md) | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290 | Y | Mar 3, 1988 | SESE | | [K874491](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR/K874491.md) | IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ | Y | Feb 25, 1988 | SESE | ## Top Applicants - Y — 8 clearances - Travenol Laboratories, S.A. — 4 clearances - Abbott Laboratories — 3 clearances - Ivy Medical, Inc. — 3 clearances - Alexander Mfg. Co. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LDR) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com