Cleared Traditional

K912280 - BI-TEMP TEMPERATURE MONITOR

K912280 is an FDA 510(k) clearance for BI-TEMP TEMPERATURE MONITOR, manufactured by Respiratory Support Products, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K912280 · Respiratory Support Products, Inc. · General Hospital
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Oct 1991
Decision
147d
Days
Class 2
Risk

K912280 is an FDA 510(k) clearance for the BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Respiratory Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on October 17, 1991 after a review of 147 days - within the typical 510(k) review window.

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 Respiratory Support Products, Inc. devices

FDA 510(k) Submission Details - K912280

510(k) Number K912280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1991
Decision Date October 17, 1991
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 129d · This submission: 147d
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 377
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K912280.
MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
K920469 · Respiratory Support Products, Inc. · Sep 1992
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
K912742 · Spacelabs, Inc. · Apr 1992
BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
K913082 · Respiratory Support Products, Inc. · Dec 1991
BI-TEMP TEMPERATURE MONITOR TM-201D
K913083 · Respiratory Support Products, Inc. · Oct 1991
1.1, 1.2, 1.3 TEMPERATURE PROBES
K912650 · Vital Signs, Inc. · Aug 1991
TEMPERATURE WELL PROBE, TWP SERIES
K910868 · Gish Biomedical, Inc. · Apr 1991