Cleared Traditional

K912742 - ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE

K912742 is an FDA 510(k) clearance for ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE, manufactured by Spacelabs, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K912742 · Spacelabs, Inc. · General Hospital
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Apr 1992
Decision
304d
Days
Class 2
Risk

K912742 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on April 20, 1992 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Spacelabs, Inc. devices

FDA 510(k) Submission Details - K912742

510(k) Number K912742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1991
Decision Date April 20, 1992
Days to Decision 304 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
175d slower than avg
Panel avg: 129d · This submission: 304d
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 362
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K912742.
OMRON TYMPANIC THERMOMETER MC-500
K922344 · Omron Healthcare, Inc. · Jun 1993
ADAP-TEMP TEMPERATURE SENSOR ADAPTER
K921190 · Respiratory Support Products, Inc. · Mar 1993
MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
K920469 · Respiratory Support Products, Inc. · Sep 1992
BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
K913082 · Respiratory Support Products, Inc. · Dec 1991
BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D
K912280 · Respiratory Support Products, Inc. · Oct 1991
BI-TEMP TEMPERATURE MONITOR TM-201D
K913083 · Respiratory Support Products, Inc. · Oct 1991