Cleared Traditional

K881368 - CLINICAL ELECTONIC THERMOMETERS

K881368 is an FDA 510(k) clearance for CLINICAL ELECTONIC THERMOMETERS, manufactured by Sheridan Catheter Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K881368 · Sheridan Catheter Corp. · General Hospital
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Jul 1988
Decision
22d
Days
Class 2
Risk

K881368 is an FDA 510(k) clearance for the CLINICAL ELECTONIC THERMOMETERS. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on July 13, 1988 after a review of 22 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 Sheridan Catheter Corp. devices

FDA 510(k) Submission Details - K881368

510(k) Number K881368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date July 13, 1988
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 398
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K881368.
DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)
K883793 · Yellow Springs Instrument Co., Inc. · Nov 1988
TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA
K884119 · S & W Medico Teknik · Nov 1988
CLINICAL ELECTRONIC THERMOMETERS
K882127 · Sheridan Catheter Corp. · Aug 1988
DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
K882304 · Abco Dealers, Inc. · Jul 1988
ADAP-TEMP, MODEL: AT-100
K874694 · Respiratory Support Products, Inc. · Mar 1988
HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
K874514 · Mallinckrodt Critical Care · Jan 1988