Cleared Traditional

K943270 - SURFACE TEMPERATURE PROBES

K943270 is the FDA 510(k) clearance for SURFACE TEMPERATURE PROBES by Coast Medical, Inc.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K943270 · Coast Medical, Inc. · General Hospital
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Dec 1994
Decision
151d
Days
Class 2
Risk

K943270 is an FDA 510(k) clearance for the SURFACE TEMPERATURE PROBES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Coast Medical, Inc. (Orange, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 151 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 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 Coast Medical, Inc. devices

Submission Details

510(k) Number K943270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1994
Decision Date December 05, 1994
Days to Decision 151 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 129d · This submission: 151d
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 242
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K943270.
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837 · Ge Healthcare · Apr 2005
SURETEMP PLUS
K030580 · Welch Allyn, Inc. · May 2003
MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
K955846 · Y · Oct 1996
B-D DIGITAL THERMOMETER
K935267 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600
K934482 · Vital Signs, Inc. · May 1994
EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
K925792 · Deroyal Industries, Inc. · Apr 1994