Cleared Traditional

K930930 - COAST MEDICAL, INC. RECTAL PROBE

K930930 is an FDA 510(k) clearance for COAST MEDICAL, manufactured by Coast Medical Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 367-day FDA review.

K930930 · Coast Medical Corp. · General Hospital
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Feb 1994
Decision
367d
Days
Class 2
Risk

K930930 is an FDA 510(k) clearance for the COAST MEDICAL, INC. RECTAL PROBE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Coast Medical Corp. (Orange, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 367 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 Coast Medical Corp. devices

FDA 510(k) Submission Details - K930930

510(k) Number K930930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1993
Decision Date February 25, 1994
Days to Decision 367 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
238d slower than avg
Panel avg: 129d · This submission: 367d
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 591
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K930930.
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
EXTRACORPOREAL TEMPERATURE SENSOR
K935603 · Smiths Industries Medical Systems, 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