Cleared Traditional

K972259 - PRO CHECK DIGITAL PACIFIER THERMOMETER

K972259 is an FDA 510(k) clearance for PRO CHECK DIGITAL PACIFIER THERMOMETER, manufactured by Micro Weiss Electronics. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K972259 · Micro Weiss Electronics · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
23d
Days
Class 2
Risk

K972259 is an FDA 510(k) clearance for the PRO CHECK DIGITAL PACIFIER THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Micro Weiss Electronics (Great Neck,, US). The FDA issued a Cleared decision on July 10, 1997 after a review of 23 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 Micro Weiss Electronics devices

FDA 510(k) Submission Details - K972259

510(k) Number K972259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1997
Decision Date July 10, 1997
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
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 405
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K972259.
QUICK CHECK INSTANT THERMOMETER
K971831 · Ejb Medical, Inc. · May 1998
B-D ASSURE EAR THERMOMETER
K971994 · Becton Dickinson Consumer Products · May 1998
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
BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)
K964605 · Thermoscan, Inc. · May 1997