Cleared Traditional

K852087 - CAPIOX LUER DESIGN THERMISTORS & CAPIOX...

K852087 is an FDA 510(k) clearance for CAPIOX LUER DESIGN THERMISTORS & CAPIOX..., manufactured by Terumo Medical Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K852087 · Terumo Medical Corp. · General Hospital
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Jun 1985
Decision
45d
Days
Class 2
Risk

K852087 is an FDA 510(k) clearance for the CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on June 27, 1985 after a review of 45 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K852087

510(k) Number K852087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1985
Decision Date June 27, 1985
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
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 372
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K852087.
CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM
K852454 · Gambro, Inc. · Aug 1985
B-D DIGITAL FEVER THERMOMETER
K852954 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
TOSHIBA DIGITAL CLINICAL THERMOMTER
K852903 · Toshiba Medical Systems · Jul 1985
YSI MODEL 791/799 DISP TEMP PROBE & 7900 EX CABLE
K852246 · Yellow Springs Instrument Co., Inc. · Jun 1985
THERMOMED
K851704 · Draeger Medical, Inc. · May 1985
CLINICAL ELECTRONIC THERMOMETERS
K850244 · Sheridan Catheter Corp. · Apr 1985