Cleared Traditional

K813423 - THERMOMETER SHEATHS

K813423 is an FDA 510(k) clearance for THERMOMETER SHEATHS, manufactured by Abco Dealers, Inc.. The device is a Class 2 General Hospital device with product code FLK cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K813423 · Abco Dealers, Inc. · General Hospital
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Dec 1981
Decision
11d
Days
Class 2
Risk

K813423 is an FDA 510(k) clearance for the THERMOMETER SHEATHS. Classified as Thermometer, Clinical Mercury (product code FLK), Class II - Special Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1981 after a review of 11 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 Abco Dealers, Inc. devices

FDA 510(k) Submission Details - K813423

510(k) Number K813423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1981
Decision Date December 18, 1981
Days to Decision 11 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
118d faster than avg
Panel avg: 129d · This submission: 11d
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 K813423.
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
THERMOMETERS
K813424 · Abco Dealers, Inc. · Dec 1981
DISPOSABLE TEMPERATURE PROBE
K792426 · Hospitak, Inc. · Jan 1980
TEMPO2-II DISPOSABLE THERMOMETERS
K790891 · Airlife, Inc. · Jun 1979