Cleared Traditional

K813468 - ACC-U-THERM TEMPERATURE MONITOR

K813468 is an FDA 510(k) clearance for ACC-U-THERM TEMPERATURE MONITOR, 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 27-day FDA review.

K813468 · Diatek, Inc. · General Hospital
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Jan 1982
Decision
27d
Days
Class 2
Risk

K813468 is an FDA 510(k) clearance for the ACC-U-THERM TEMPERATURE MONITOR. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Diatek, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1982 after a review of 27 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 - K813468

510(k) Number K813468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1981
Decision Date January 07, 1982
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 495
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K813468.
CONPHAR DIGITAL THERMOMETER
K813306 · Conphar, Inc. · Jan 1982
SERIES 400 DISPOSABLE TEMPERATURE PROBE
K813639 · Yellow Springs Instrument Co., Inc. · Jan 1982
WA-2000 TEMPERATURE INDICATOR
K813402 · Wallach Surgical Devices, Inc. · Jan 1982
MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER
K813409 · Yellow Springs Instrument Co., Inc. · Dec 1981
PROBE COVER
K810474 · Narco Air-Shields · Mar 1981
TEMPERATURE FUNCTION BLOCK
K810173 · Honeywell, Inc. · Feb 1981