Cleared Traditional

K971045 - BASIS FLEXIBLE TIP DIGITAL THERMOMETER

K971045 is an FDA 510(k) clearance for BASIS FLEXIBLE TIP 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 42-day FDA review.

K971045 · Polymedica Industries, Inc. · General Hospital
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May 1997
Decision
42d
Days
Class 2
Risk

K971045 is an FDA 510(k) clearance for the BASIS FLEXIBLE TIP 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 May 2, 1997 after a review of 42 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.

View all Polymedica Industries, Inc. devices

FDA 510(k) Submission Details - K971045

510(k) Number K971045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1997
Decision Date May 02, 1997
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 K971045.
FLEXIBLE TIP DIGITAL THERMOMETER
K974195 · K-Jump Health Co., Ltd. · Feb 1998
ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
K970011 · Medical Data Electronics · Jul 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010
K971866 · Alexander Mfg. Co. · Jul 1997
ALEXANDER MANUFACTURING COMPANY
K970271 · Alexander Mfg. Co. · Apr 1997
MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
K955846 · Y · Oct 1996
BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
K962991 · Polymedica Industries, Inc. · Sep 1996