Cleared Traditional

K930680 - THERMOSCAN INSTANT THERMOMETER IR-5000

K930680 is an FDA 510(k) clearance for THERMOSCAN INSTANT THERMOMETER IR-5000, manufactured by Thermoscan, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 525-day FDA review.

K930680 · Thermoscan, Inc. · General Hospital
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Jul 1994
Decision
525d
Days
Class 2
Risk

K930680 is an FDA 510(k) clearance for the THERMOSCAN INSTANT THERMOMETER IR-5000. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Thermoscan, Inc. (San Diego, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 525 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Thermoscan, Inc. devices

FDA 510(k) Submission Details - K930680

510(k) Number K930680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1993
Decision Date July 20, 1994
Days to Decision 525 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
396d slower than avg
Panel avg: 129d · This submission: 525d
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 406
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K930680.
R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 5650
K951403 · R & D Batteries, Inc. · Aug 1995
R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131
K951404 · R & D Batteries, Inc. · Aug 1995
B-D DIGITAL THERMOMETER
K935267 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
ELECTRONIC THERMOMETERS
K940686 · American Diagnostic Corp. · Jul 1994
VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600
K934482 · Vital Signs, Inc. · May 1994
EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
K925792 · Deroyal Industries, Inc. · Apr 1994