Cleared Traditional

ACCUTEMP-PROBE (K970686) - FDA 510(k) Clearance

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

K970686 · Kentec Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
181d
Days
Class 2
Risk

K970686 is an FDA 510(k) clearance for the ACCUTEMP-PROBE. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Kentec Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on August 25, 1997 after a review of 181 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - 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 Kentec Medical, Inc. devices

Submission Details

510(k) Number K970686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1997
Decision Date August 25, 1997
Days to Decision 181 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
52d slower than avg
Panel avg: 129d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMT Warmer, Infant Radiant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5130
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 - FMT Warmer, Infant Radiant

All 91
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K970686.
Babyroo TN300
K243606 · Draeger Medical Systems, Inc. · Jan 2025
Babyroo TN300
K230278 · Draeger Medical Systems, Inc. · May 2023
Giraffe Omnibed Carestation CS1
K213551 · Datex-Ohmeda, Inc. · Mar 2022
Panda iRes Warmer, Giraffe Warmer
K201628 · Ge Healthcare · Feb 2021
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
K200319 · Deroyal Industries, Inc. · Apr 2020
Hydro-Temp Neonatal Skin Temperature Probe Cover
K191425 · Deroyal Industries, Inc. · Jan 2020