Cleared Traditional

K893418 - MYOCARDIAL PROBE THERMOMETER CODE 64000

K893418 is an FDA 510(k) clearance for MYOCARDIAL PROBE THERMOMETER CODE 64000, manufactured by Dlp, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K893418 · Dlp, Inc. · General Hospital
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Sep 1989
Decision
126d
Days
Class 2
Risk

K893418 is an FDA 510(k) clearance for the MYOCARDIAL PROBE THERMOMETER CODE 64000. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - 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 Dlp, Inc. devices

FDA 510(k) Submission Details - K893418

510(k) Number K893418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date September 05, 1989
Days to Decision 126 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
3d faster than avg
Panel avg: 129d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
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 - FLL Continuous Measurement Thermometer

All 550
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K893418.
KEJUMP DIGITAL CLINICAL THERMOMETER
K903590 · K-Jump Health Co., Ltd. · Oct 1990
BD FLEXIBLE DIGITAL THERMOMETER
K902624 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
IVAC MODEL 2090 INFRA RED THERMOMETER
K896914 · Y · Mar 1990
ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER
K890823 · Sheridan Catheter Corp. · May 1989
MODEL 1000 ELECTRONIC CLINICAL THERMOMETER
K885187 · Mon-A-Therm, Inc. · Mar 1989
CLINICAL ELECTRONIC THERMOMETERS
K884765 · Sheridan Catheter Corp. · Feb 1989