Cleared Traditional

K010502 - MODEL THERMO TEK QUICKCARE

K010502 is an FDA 510(k) clearance for MODEL THERMO TEK QUICKCARE, manufactured by Saat , Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K010502 · Saat , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
6d
Days
Class 2
Risk

K010502 is an FDA 510(k) clearance for the MODEL THERMO TEK QUICKCARE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Saat , Ltd. (Crofton, US). The FDA issued a Cleared decision on February 27, 2001 after a review of 6 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.

FDA 510(k) Submission Details - K010502

510(k) Number K010502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2001
Decision Date February 27, 2001
Days to Decision 6 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 129d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
NED DEVINE JR.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 739
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K010502.
FUNET AMY MAMA BODY THERMOMETER
K003326 · Funai Radio & Communications Corp. · Apr 2001
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
K010462 · Avita Corporation · Apr 2001
NPAC MULTI-USE THERMOMETER, MODEL TD400
K010224 · Norm Pacific Automation Corp. · Mar 2001
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
K002712 · Saat , Ltd. · Feb 2001
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+
K010238 · Actherm, Inc. · Feb 2001
GEON DIGITAL CLINICAL THERMOMETER
K003223 · Geon Corp. · Jan 2001

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K010502 · MODEL THERMO TEK QUICKCARE
Download PDF FDA Summary Saat , Ltd.