Cleared Traditional

K952159 - BASIS DIGITAL THERMOMETER

K952159 is an FDA 510(k) clearance for BASIS DIGITAL THERMOMETER, manufactured by Polymedica Industries, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K952159 · Polymedica Industries, Inc. · General Hospital
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Sep 1995
Decision
137d
Days
Class 2
Risk

K952159 is an FDA 510(k) clearance for the BASIS DIGITAL THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on September 22, 1995 after a review of 137 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 Polymedica Industries, Inc. devices

FDA 510(k) Submission Details - K952159

510(k) Number K952159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date September 22, 1995
Days to Decision 137 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
8d slower than avg
Panel avg: 129d · This submission: 137d
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 398
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K952159.
ENDOCARE ELECTORNIC THERMOMETER SYSTEM
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YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
K962070 · Yellow Springs Instrument Co., Inc. · Jul 1996
OLYMPIC INFANT THERMOMETER
K954434 · Olympic Medical Corp. · Dec 1995
R&D BATTRIES, INC. PART NUMBERS 5601, 5602, 5624 AND 5626
K951274 · R & D Batteries, Inc. · Aug 1995
R&D BATTERIES, INC. PART NUMBERS 5453, 5474, 5513 AND 5595
K951275 · R & D Batteries, Inc. · Aug 1995
R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438
K951276 · R & D Batteries, Inc. · Aug 1995