Nobles-Lai Engineering Infusion Pump
by Nobles-Lai Engineering, Inc.
510(k) K895688
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895688 | Date26 Feb 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Nobles-Lai Engineering Infusion Pump is a Withdrawal/Infusion Pump, classified under FDA regulation 870.1800. This device is designed to deliver or withdraw fluids at controlled rates, ensuring precise dosing for medical applications within the cardiovascular specialty. Its primary function involves automated fluid management, which is critical in clinical settings requiring accurate infusion or withdrawal therapies.
This infusion pump is intended for use in hospital environments and has received FDA 510(k) clearance under product code DQI, with a decision of Substantially Equivalent (SESE). It is classified as a Class II device and is regulated under the Cardiovascular advisory committee. The device is not described as single-use or reusable in the available data, nor are MRI safety or sterility specifications provided. The pump’s regulatory filing date is September 22, 1989, with clearance granted on February 26, 1990.