Cleared Traditional

K893602 - GLASS MERCURY FILLED THERMOMETERS

K893602 is an FDA 510(k) clearance for GLASS MERCURY FILLED THERMOMETERS, manufactured by Smith & Nephew United, Inc.. The device is a Class 2 General Hospital device with product code FLK cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K893602 · Smith & Nephew United, Inc. · General Hospital
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Aug 1989
Decision
85d
Days
Class 2
Risk

K893602 is an FDA 510(k) clearance for the GLASS MERCURY FILLED THERMOMETERS. Classified as Thermometer, Clinical Mercury (product code FLK), Class II - Special Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on August 8, 1989 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew United, Inc. devices

FDA 510(k) Submission Details - K893602

510(k) Number K893602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date August 08, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
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 12
Devices cleared under the same product code (FLK) and FDA review panel - the closest regulatory comparables to K893602.
GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
K960224 · Rg Ent., Inc. · Mar 1996
MEDIAID UNIVERSAL THERMOMETER
K941673 · Polymedica Industries, Inc. · Aug 1994
CLINICAL MERCURY THERMOMETER
K897054 · Cypress Medical Products, Ltd. · Mar 1990
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