Cleared Abbreviated

IR FOREHEAD THERMOMETER, MODEL HV-T36 (K032612) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K032612 · Oriental Inspiration, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
178d
Days
Class 2
Risk

K032612 is an FDA 510(k) clearance for the IR FOREHEAD THERMOMETER, MODEL HV-T36. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Oriental Inspiration, Ltd. (Alpharetta, US). The FDA issued a Cleared decision on February 19, 2004 after a review of 178 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Oriental Inspiration, Ltd. devices

Submission Details

510(k) Number K032612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2003
Decision Date February 19, 2004
Days to Decision 178 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 129d · This submission: 178d
Pathway characteristics
Standards-based clearance path.

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 191
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K032612.
Medline Disposable Electronic Thermometer Probe Cover
K173113 · Medline Industries, Inc. · Jan 2018
Kinsa QuickCare Thermometer
K173730 · Kinsa, Inc. · Jan 2018
Temperature Probe, Affinity Temperature Probe
K160091 · Medtronic, Inc. · May 2016
B-D DIGITAL THERMOMETER
K935267 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
BD FLEXIBLE DIGITAL THERMOMETER
K902624 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
B-D DIGITAL FEVER THERMOMETER
K852954 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985