Cleared Traditional

FEVER LINE AND FEVER LINE PLUS (K893803) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K893803 · Liquid Crystal Sciences, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
91d
Days
Class 2
Risk

K893803 is an FDA 510(k) clearance for the FEVER LINE AND FEVER LINE PLUS. Classified as Strip, Temperature, Forehead, Liquid Crystal (product code KPD), Class II - Special Controls.

Submitted by Liquid Crystal Sciences, Inc. (Atlanta, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Liquid Crystal Sciences, Inc. devices

Submission Details

510(k) Number K893803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date August 21, 1989
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPD Strip, Temperature, Forehead, Liquid Crystal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.