Cleared Traditional

K832635 - HI-LO TEMP TYMPANIC TEMP. SENSOR

K832635 is the FDA 510(k) clearance for HI-LO TEMP TYMPANIC TEMP. SENSOR by Mallinckrodt Critical Care. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K832635 · Mallinckrodt Critical Care · General Hospital
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Oct 1983
Decision
61d
Days
Class 2
Risk

K832635 is an FDA 510(k) clearance for the HI-LO TEMP TYMPANIC TEMP. SENSOR. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 61 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K832635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1983
Decision Date October 04, 1983
Days to Decision 61 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 129d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 332
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K832635.
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
RECTAL TEMP. TELEMETRY MONITOR
K832404 · Xomed, Inc. · Sep 1983
TEMPERATURE MODULE 242-100
K831733 · Kontron Instruments, Inc. · Aug 1983
LME TEMP. MONITOR
K832042 · Litton Medical Electronics · Aug 1983