Model 600 Syringe Pump
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K891237 FDA 510(k)
- FDA Product Code
- FRN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 600 Syringe Pump is an infusion pump designed to deliver controlled volumes of intravenous fluids or medications at precise flow rates. It operates by drawing fluid from a syringe and administering it to a patient via a connected tubing system, ensuring accurate dosing and flow regulation for clinical applications in general hospital settings.
This device is intended for single-use in hospital environments and requires no special sterility beyond standard medical device preparation. It is classified as a Class II medical device under FDA regulations and has received a 510(k) clearance (K891237) for use in general hospital settings. The pump is supplied as a standalone unit and must be operated in accordance with manufacturer instructions to ensure proper functionality and patient safety.
Frequently asked questions
What clinical settings is the Model 600 Syringe Pump intended for use in, and how does it ensure precise dosing for patients?
The Model 600 Syringe Pump is designed specifically for general hospital settings, where controlled delivery of intravenous fluids or medications is required. It achieves precise dosing by drawing fluid from a syringe and administering it through connected tubing, allowing clinicians to regulate flow rates accurately for patient safety and treatment efficacy.
Is the Model 600 Syringe Pump meant for single-use or repeated use in a hospital environment, and what sterility requirements apply?
The Model 600 Syringe Pump is intended for single-use in hospital environments. No special sterility beyond standard medical device preparation is required, meaning it should be handled and stored according to general aseptic practices for medical devices.
How is the Model 600 Syringe Pump supplied, and what regulatory pathway was followed for its approval?
The Model 600 Syringe Pump is supplied as a standalone unit, ready for immediate use in clinical settings. It received FDA 510(k) clearance (K891237) under the traditional review pathway, demonstrating substantial equivalence to a predicate device for infusion pumps in general hospital use.
Are there different models or sizes available for the Model 600 Syringe Pump, or is it a single standardized device?
The provided data does not specify multiple models or sizes for the Model 600 Syringe Pump. It is described as a singular device designed for general hospital infusion applications, implying a standardized design for controlled fluid delivery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 3M 600 Syringe Pump - allmed.wiki, MODEL 600 SYRINGE PUMP (K891237) — FDA 510 (k) | Innolitics, K933005 - AVI MODEL 600 SYRINGE PUMP | FDA 510 (k), 3M Health Care Avi 600 Syringe Pump - allmed.wiki, Model 600 Syringe Pump - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K891237 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K891237 24 fields · synced Sep 19, 2026