Cleared Traditional

K895703 - DIATEK MODEL 700 THERMOMETER

K895703 is an FDA 510(k) clearance for DIATEK MODEL 700 THERMOMETER, manufactured by Diatek, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K895703 · Diatek, Inc. · General Hospital
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Dec 1989
Decision
76d
Days
Class 2
Risk

K895703 is an FDA 510(k) clearance for the DIATEK MODEL 700 THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Diatek, Inc. (San Diego, US). The FDA issued a Cleared decision on December 7, 1989 after a review of 76 days - a notably fast clearance cycle.

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: 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 Diatek, Inc. devices

FDA 510(k) Submission Details - K895703

510(k) Number K895703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1989
Decision Date December 07, 1989
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
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 493
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K895703.
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K890823 · Sheridan Catheter Corp. · May 1989
MODEL 1000 ELECTRONIC CLINICAL THERMOMETER
K885187 · Mon-A-Therm, Inc. · Mar 1989