Star 55
510(k) K080173
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080173 | Date8 Feb 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MWI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Star 55 is a multi-parameter patient monitoring system designed to monitor a single adult, pediatric, or neonatal patient's vital signs at the bedside or during intra-hospital transport. It is intended to be used with appropriate accessories. The device is classified under the product code MWI. The Star 55 is substantially equivalent to other devices on the market.
The Star 55 is supplied by Larsen & Toubro Limited and has received FDA 510(k) clearance, indicated by the clearance number K080173. The device is available in a specific model, the Star 55 Model 100. It is designed for use in a clinical setting, such as a hospital, and is intended for monitoring patients' vital signs.
Other devices from Larsen & Toubro Limited
Questions
AI-generated answers, 26 Sep 2026
What is the Star 55 used for?
The Star 55 is a multi-parameter patient monitoring system designed to monitor a single adult, pediatric, or neonatal patient's vital signs at the bedside or during intra-hospital transport. It is intended to be used with appropriate accessories for continuous monitoring in clinical settings such as hospitals.
How is the Star 55 supplied and what model is available?
The Star 55 is supplied by Larsen & Toubro Limited and is available in a specific model, the Star 55 Model 100. It is designed for use in clinical environments and requires appropriate accessories for operation as described in the device documentation.
Is the Star 55 sterile or single-use?
The Star 55 is a reusable electronic monitoring system and is not supplied sterile. It is intended for multiple uses in a clinical setting after proper cleaning and disinfection according to the manufacturer's instructions, as it is not a disposable or single-use device.
What regulatory clearance does the Star 55 have?
The Star 55 has received FDA 510(k) clearance under clearance number K080173, which indicates it is substantially equivalent to other legally marketed devices. This clearance allows it to be marketed in the United States for its intended use.