Cleared Traditional

K830429 - WEIL PERFUSOMETER #100

K830429 is an FDA 510(k) clearance for WEIL PERFUSOMETER #100, manufactured by Wescor, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K830429 · Wescor, Inc. · General Hospital
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Oct 1983
Decision
264d
Days
Class 2
Risk

K830429 is an FDA 510(k) clearance for the WEIL PERFUSOMETER #100. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Wescor, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 264 days - an extended review 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: 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 Wescor, Inc. devices

FDA 510(k) Submission Details - K830429

510(k) Number K830429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1983
Decision Date October 31, 1983
Days to Decision 264 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 129d · This submission: 264d
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 529
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K830429.
TYCOS SELF-CHECK/DIGITAL FEVER THERMO
K842132 · Sybron Corp. · Jul 1984
TEMPROBE MONITOR
K840648 · Vital Signs, Inc. · Jun 1984
SHILEY DISPOS. TEMP. PROBES
K833981 · Shiley, Inc. · Mar 1984
HI-LO TEMP TYMPANIC TEMP. SENSOR
K832635 · Mallinckrodt Critical Care · Oct 1983
RECTAL TEMP. TELEMETRY MONITOR
K832404 · Xomed, Inc. · Sep 1983
TEMPERATURE MODULE 242-100
K831733 · Kontron Instruments, Inc. · Aug 1983