Cleared Traditional

K926030 - KLEAR-TEMP

K926030 is the FDA 510(k) clearance for KLEAR-TEMP by Cas Medical Systems, Inc.. It is a Class 2 General Hospital device (product code FMT) cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K926030 · Cas Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
450d
Days
Class 2
Risk

K926030 is an FDA 510(k) clearance for the KLEAR-TEMP. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on February 24, 1994 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Cas Medical Systems, Inc. devices

Submission Details

510(k) Number K926030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date February 24, 1994
Days to Decision 450 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
321d slower than avg
Panel avg: 129d · This submission: 450d
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 24
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K926030.
MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K072157 · Ohmeda Medical · Aug 2007
GIRAFFE AND PANDA WARMER
K070377 · Ohmeda Medical · Jul 2007
INFANT WARMER SYSTEM
K963058 · Ohmeda Medical · Oct 1996
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · Deroyal Industries, Inc. · Jan 1994
OHIO INFANT WARMER SYSTEM
K921766 · Ohmeda Medical · Apr 1993
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
K884160 · Ohmeda Medical · Nov 1988