Cleared Traditional

CT-1000A SYSTEM (K896779) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896779 · Bio-Monitor, Inc. · General Hospital
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Jun 1990
Decision
182d
Days
Class 2
Risk

K896779 is an FDA 510(k) clearance for the CT-1000A SYSTEM. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Bio-Monitor, Inc. (Great Neck, US). The FDA issued a Cleared decision on June 1, 1990 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Monitor, Inc. devices

Submission Details

510(k) Number K896779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date June 01, 1990
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
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 199
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K896779.
B-D DIGITAL THERMOMETER
K935267 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
DIGITAL THERMOMETER KITS
K905025 · Abco Dealers, Inc. · Feb 1991
BD FLEXIBLE DIGITAL THERMOMETER
K902624 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
K882304 · Abco Dealers, Inc. · Jul 1988
THERMOMETER SHEATHS
K871465 · Abco Dealers, Inc. · May 1987
B-D DIGITAL FEVER THERMOMETER
K852954 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985