Cleared Traditional

K971198 - BABYTHERM 8004 BABYTHERM 8010

K971198 is an FDA 510(k) clearance for BABYTHERM 8004 BABYTHERM 8010, manufactured by Drager, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K971198 · Drager, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
186d
Days
Class 2
Risk

K971198 is an FDA 510(k) clearance for the BABYTHERM 8004 BABYTHERM 8010. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Drager, Inc. (Chantilly, US). The FDA issued a Cleared decision on October 3, 1997 after a review of 186 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 Drager, Inc. devices

FDA 510(k) Submission Details - K971198

510(k) Number K971198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1997
Decision Date October 03, 1997
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMT Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K971198.
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