Cleared Traditional

K882304 - DIGITAL THERMOMETER SHEATHS (ORAL AND R...

K882304 is the FDA 510(k) clearance for DIGITAL THERMOMETER SHEATHS (ORAL AND R... by Abco Dealers, Inc.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K882304 · Abco Dealers, Inc. · General Hospital
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Jul 1988
Decision
39d
Days
Class 2
Risk

K882304 is an FDA 510(k) clearance for the DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on July 12, 1988 after a review of 39 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K882304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1988
Decision Date July 12, 1988
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 318
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K882304.
TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA
K884119 · S & W Medico Teknik · Nov 1988
CLINICAL ELECTRONIC THERMOMETERS
K882127 · Sheridan Catheter Corp. · Aug 1988
CLINICAL ELECTONIC THERMOMETERS
K881368 · Sheridan Catheter Corp. · Jul 1988
HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
K874514 · Mallinckrodt Critical Care · Jan 1988
HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
K874568 · Mallinckrodt Critical Care · Jan 1988
HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
K874404 · Mallinckrodt Critical Care · Nov 1987