Cleared Traditional

K893602 - GLASS MERCURY FILLED THERMOMETERS

K893602 is the FDA 510(k) clearance for GLASS MERCURY FILLED THERMOMETERS by Smith & Nephew United, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 7
Devices cleared under the same product code (FLK) and FDA review panel - the closest regulatory comparables to K893602.
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
TEMPO2-II DISPOSABLE THERMOMETERS
K790891 · Airlife, Inc. · Jun 1979
THERMOMETER KIT
K780591 · Abco Dealers, Inc. · Apr 1978
THERMOMETER SHEATHS
K772365 · Medline Industries, Inc. · Jan 1978