Cleared Traditional

K935603 - EXTRACORPOREAL TEMPERATURE SENSOR

K935603 is an FDA 510(k) clearance for EXTRACORPOREAL TEMPERATURE SENSOR, manufactured by Smiths Industries Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K935603 · Smiths Industries Medical Systems, Inc. · General Hospital
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Feb 1994
Decision
89d
Days
Class 2
Risk

K935603 is an FDA 510(k) clearance for the EXTRACORPOREAL TEMPERATURE SENSOR. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Smiths Industries Medical Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on February 15, 1994 after a review of 89 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 Smiths Industries Medical Systems, Inc. devices

FDA 510(k) Submission Details - K935603

510(k) Number K935603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date February 15, 1994
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 K935603.
EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
K925792 · Deroyal Industries, Inc. · Apr 1994
ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR
K934964 · Electromedics, Inc. · Mar 1994
EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR
K925791 · Deroyal Industries, Inc. · Feb 1994
ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR
K933832 · Electromedics, Inc. · Jan 1994
R & D BATTERIES, INC. PART # 5003, 5198, 5253
K933642 · R & D Batteries, Inc. · Jan 1994
MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA
K915633 · S & W Medico Teknik · Jun 1993