Cleared Traditional

K923225 - LORREX HEALTH PRODUCTS - CLINICAL MERCU...

K923225 is an FDA 510(k) clearance for LORREX HEALTH PRODUCTS - CLINICAL MERCU..., manufactured by Lorrex Health Products. The device is a Class 2 General Hospital device with product code FLK cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K923225 · Lorrex Health Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
342d
Days
Class 2
Risk

K923225 is an FDA 510(k) clearance for the LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME. Classified as Thermometer, Clinical Mercury (product code FLK), Class II - Special Controls.

Submitted by Lorrex Health Products (Secaucus, US). The FDA issued a Cleared decision on June 8, 1993 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2920 - 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. Elevated predicate reliance profile. 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 Lorrex Health Products devices

FDA 510(k) Submission Details - K923225

510(k) Number K923225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1992
Decision Date June 08, 1993
Days to Decision 342 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 129d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLK Device Classification - Class 2, Special Controls

Product Code FLK Thermometer, Clinical Mercury
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2920
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.

Regulatory Peers - FLK Thermometer, Clinical Mercury

All 10
Devices cleared under the same product code (FLK) and FDA review panel - the closest regulatory comparables to K923225.
CLINICAL MERCURY THERMOMETER
K897054 · Cypress Medical Products, Ltd. · Mar 1990
GLASS MERCURY FILLED THERMOMETERS
K893602 · Smith & Nephew United, Inc. · Aug 1989
DISPOSABLE THERMOMETERS
K822502 · Hudson Oxygen Therapy Sales Co. · Sep 1982
THERMOMETER SHEATHS
K813423 · Abco Dealers, Inc. · Dec 1981
THERMOMETERS
K813424 · Abco Dealers, Inc. · Dec 1981
DISPOSABLE TEMPERATURE PROBE
K792426 · Hospitak, Inc. · Jan 1980