Cleared Traditional

K881909 - TOSHIBA DIGITAL CLINICAL THERMOMETER

K881909 is an FDA 510(k) clearance for TOSHIBA DIGITAL CLINICAL THERMOMETER, manufactured by Toshiba Glass Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K881909 · Toshiba Glass Co., Ltd. · General Hospital
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May 1988
Decision
20d
Days
Class 2
Risk

K881909 is an FDA 510(k) clearance for the TOSHIBA DIGITAL CLINICAL THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Toshiba Glass Co., Ltd. (Tokyo, 105 Japan, JP). The FDA issued a Cleared decision on May 26, 1988 after a review of 20 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 Toshiba Glass Co., Ltd. devices

FDA 510(k) Submission Details - K881909

510(k) Number K881909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1988
Decision Date May 26, 1988
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
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 608
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K881909.
CLINICAL ELECTRONIC THERMOMETERS
K882127 · Sheridan Catheter Corp. · Aug 1988
CLINICAL ELECTONIC THERMOMETERS
K881368 · Sheridan Catheter Corp. · Jul 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
MON-A-THERM'S SKIN TEMPERATURE SENSOR
K875234 · Mon-A-Therm, Inc. · Jan 1988