Cleared Traditional

SURETEMP (K943695) - FDA 510(k) Clearance

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

K943695 · Advanced Bioresearch Assoc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
266d
Days
Class 2
Risk

K943695 is an FDA 510(k) clearance for the SURETEMP. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Advanced Bioresearch Assoc. (Lajolla, US). The FDA issued a Cleared decision on April 21, 1995 after a review of 266 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 Advanced Bioresearch Assoc. devices

Submission Details

510(k) Number K943695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1994
Decision Date April 21, 1995
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 129d · This submission: 266d
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 191
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K943695.
Medline Disposable Electronic Thermometer Probe Cover
K173113 · Medline Industries, Inc. · Jan 2018
Kinsa QuickCare Thermometer
K173730 · Kinsa, Inc. · Jan 2018
Temperature Probe, Affinity Temperature Probe
K160091 · Medtronic, Inc. · May 2016
B-D DIGITAL THERMOMETER
K935267 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
BD FLEXIBLE DIGITAL THERMOMETER
K902624 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
B-D DIGITAL FEVER THERMOMETER
K852954 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985