Snapdose Device
by Abbott Laboratories 510(k)
Active
510(k) K955410
Overview
The Snapdose Device is a Set, Administration, Intravascular device (Product Code FPA) designed for the preparation and administration of intravenous medications. It facilitates the accurate dispensing of liquid pharmaceuticals into intravenous lines, ensuring precise dosing and reducing the risk of medication errors in clinical settings. The device is intended for use in hospital environments where controlled intravenous therapy is required.
This device is supplied as a single-use item and is regulated under FDA 510(k) clearance (K955410) with a Traditional review pathway. It was authorized for use in 1996 and falls under the classification of Class II with Special Controls. Storage and handling should comply with standard sterile medical device protocols, as it is intended for direct patient administration in intravenous therapy. No additional regulatory markings or sterility certifications are explicitly stated beyond its FDA clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955410 | Date6 May 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Snapdose Device used for?
The Snapdose Device is designed specifically for preparing and administering intravenous medications in hospital environments. It helps healthcare providers deliver accurate liquid pharmaceutical doses directly into intravenous lines, minimizing the risk of dosing errors during controlled intravenous therapy.
Is the Snapdose Device single-use or reusable?
The Snapdose Device is intended for single-use only. This design ensures sterility and safety for direct patient administration, adhering to standard sterile medical device protocols. Reuse is not recommended or supported.
How should the Snapdose Device be stored?
The Snapdose Device should be stored according to standard sterile medical device guidelines. Since it is a single-use item, it must remain unopened and protected from contamination until use. Follow manufacturer instructions for optimal shelf life and handling.
What regulatory pathway does the Snapdose Device follow?
The Snapdose Device was authorized through the FDA’s 510(k) clearance process under the Traditional review pathway, with a clearance number of K955410. It was classified as substantially equivalent to a predicate device and falls under Class II with Special Controls.
What types of hospitals or settings is this device intended for?
The Snapdose Device is intended for use in general hospital environments where precise intravenous medication administration is required. Its design supports controlled therapy settings, such as inpatient wards or critical care units, where accurate dosing is critical.