Cleared Traditional

K881670 - ACCUTEMP PLUS

K881670 is the FDA 510(k) clearance for ACCUTEMP PLUS by Sentry Medical Products, Inc.. It is a Class 2 General Hospital device (product code FMT) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K881670 · Sentry Medical Products, Inc. · General Hospital
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Nov 1988
Decision
218d
Days
Class 2
Risk

K881670 is an FDA 510(k) clearance for the ACCUTEMP PLUS. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Sentry Medical Products, Inc. (Santa Ana, US). The FDA issued a Cleared decision on November 22, 1988 after a review of 218 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 Sentry Medical Products, Inc. devices

Submission Details

510(k) Number K881670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1988
Decision Date November 22, 1988
Days to Decision 218 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
89d slower than avg
Panel avg: 129d · This submission: 218d
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 36
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K881670.
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · Deroyal Industries, Inc. · Jan 1994
OHIO INFANT WARMER SYSTEM
K921766 · Ohmeda Medical · Apr 1993
STABILET INFANT RADIANT WARMER MODEL 2000C
K913945 · Hill-Rom, Inc. · Feb 1992
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
K884160 · Ohmeda Medical · Nov 1988
INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS
K875270 · Air-Shields, Inc. · Jan 1988
WARM WEIGH MODELS I-20/W-30 INFANT SCALE
K872742 · Air-Shields, Inc. · Oct 1987