As 70 Volumetric Infusion Pump
by Narco Scientific 510(k)
Active
510(k) K820946
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820946 | Date29 Apr 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The AS-70 Volumetric Infusion Pump is a Class II medical device classified under the FDA’s Pump, Infusion category. It is designed to deliver precise, controlled volumes of intravenous fluids or medications to patients in a hospital setting, ensuring accurate dosing and flow rates for therapeutic administration.
This device is intended for use in general hospital environments and is supplied as a reusable medical instrument. It has been granted FDA 510(k) clearance under the Premarket Notification (510(k)) process, with a decision of Substantially Equivalent (SESE) to a predicate device. The pump operates under regulatory framework 880.5725 and is intended for single-patient or multi-patient use in controlled clinical settings.
Other devices from Narco Scientific
Questions
AI-generated answers, 20 Sep 2026
Is the AS 70 Volumetric Infusion Pump designed for single-use or can it be reused in a clinical setting?
The AS 70 Volumetric Infusion Pump is explicitly described as a reusable medical instrument, meaning it is intended for use with multiple patients in controlled clinical environments like hospitals. This design aligns with its classification under the FDA’s Pump, Infusion category and its regulatory framework (880.5725), which supports multi-patient use when properly maintained and cleaned.
What types of fluids or medications can the AS 70 Volumetric Infusion Pump administer, and where is it primarily intended for use?
The AS 70 Volumetric Infusion Pump is designed to deliver intravenous fluids or medications with precise, controlled volumes. It is specifically intended for use in general hospital environments, as indicated by its advisory committee classification (General Hospital) and regulatory framework. The device ensures accurate dosing and flow rates for therapeutic administration in these settings.
How is the AS 70 Volumetric Infusion Pump regulated by the FDA, and what does this mean for its use in clinical practice?
The AS 70 Volumetric Infusion Pump received FDA 510(k) clearance under the Premarket Notification process, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it is as safe and effective as a previously approved pump in its class. Clinically, this clearance supports its use in controlled hospital settings for delivering intravenous fluids or medications, adhering to the established standards for infusion pumps in the Pump, Infusion category.
What storage or handling considerations should be taken for the AS 70 Volumetric Infusion Pump between uses, given it is reusable?
While the provided data does not specify storage conditions explicitly, the AS 70’s reusable design implies it must be cleaned, disinfected, and maintained per hospital protocols to prevent contamination or malfunction. Since it is intended for multi-patient use in controlled clinical settings, proper sterilization or high-level disinfection between uses is critical to ensure patient safety and device reliability. Always follow manufacturer guidelines and institutional policies for reprocessing reusable medical devices.