Cleared Traditional

K961357 - PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE

K961357 is an FDA 510(k) clearance for PRO-FLEX, manufactured by Intelligent Product Limited Co.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K961357 · Intelligent Product Limited Co. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 1996
Decision
130d
Days
Class 2
Risk

K961357 is an FDA 510(k) clearance for the PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Intelligent Product Limited Co. (Orem, US). The FDA issued a Cleared decision on August 16, 1996 after a review of 130 days - within the typical 510(k) review window.

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 Intelligent Product Limited Co. devices

FDA 510(k) Submission Details - K961357

510(k) Number K961357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1996
Decision Date August 16, 1996
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
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 478
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K961357.
BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
K962991 · Polymedica Industries, Inc. · Sep 1996
TALKING DIGITAL THERMOMETER
K962369 · Ultmost Industrial Corp. · Aug 1996
SENSOR SHEATH TS1
K962386 · Radiotherapeutics Corp. · Aug 1996
ENDOCARE ELECTORNIC THERMOMETER SYSTEM
K961365 · Endocare, Inc. · Aug 1996
YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
K962070 · Yellow Springs Instrument Co., Inc. · Jul 1996
LUMISCOPE MODEL 2018 THERMOMETER
K954792 · Lumiscope Co., Inc. · Jun 1996