Cleared Traditional

K910868 - TEMPERATURE WELL PROBE

K910868 is an FDA 510(k) clearance for TEMPERATURE WELL PROBE, manufactured by Gish Biomedical, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K910868 · Gish Biomedical, Inc. · General Hospital
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Apr 1991
Decision
52d
Days
Class 2
Risk

K910868 is an FDA 510(k) clearance for the TEMPERATURE WELL PROBE, TWP SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on April 22, 1991 after a review of 52 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K910868

510(k) Number K910868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1991
Decision Date April 22, 1991
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 129d · This submission: 52d
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 K910868.
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
1.1, 1.2, 1.3 TEMPERATURE PROBES
K912650 · Vital Signs, Inc. · Aug 1991
DATA RECORDER
K910118 · Healthdyne, Inc. · Feb 1991
DIGITAL THERMOMETER KITS
K905025 · Abco Dealers, Inc. · Feb 1991
KEJUMP DIGITAL CLINICAL THERMOMETER
K903590 · K-Jump Health Co., Ltd. · Oct 1990