Cleared Traditional

K984506 - SD-100 SKYEAR THERMOMETER

K984506 is an FDA 510(k) clearance for SD-100 SKYEAR THERMOMETER, manufactured by Skylark Device Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K984506 · Skylark Device Co., Ltd. · General Hospital
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Jul 1999
Decision
223d
Days
Class 2
Risk

K984506 is an FDA 510(k) clearance for the SD-100 SKYEAR THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on July 29, 1999 after a review of 223 days - an extended review 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: 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 Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K984506

510(k) Number K984506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1998
Decision Date July 29, 1999
Days to Decision 223 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 129d · This submission: 223d
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 377
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K984506.
AVITA TSO/TS1 INFRARED EAR THERMOMETER
K002182 · Avita Corporation · Dec 2000
A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER
K993116 · A&D Engineering, Inc. · Apr 2000
INFRARED EAR THERMOMETER, MODEL KI-8120
K984551 · K-Jump Health Co., Ltd. · Jan 2000
TALKING DIGITAL THERMOMETER, MODEL KV-171
K984553 · K-Jump Health Co., Ltd. · Jan 1999
BABY PACIFIER DIGITAL THERMOMETER
K981456 · K-Jump Health Co., Ltd. · Jul 1998
FLEXIBLE TIP DIGITAL THERMOMETER
K974195 · K-Jump Health Co., Ltd. · Feb 1998