Cleared Traditional

K971695 - SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER

K971695 is an FDA 510(k) clearance for SERVO-CONTROL COSYCOT INFANT WARMER, manufactured by Fisher & Paykel Electronics , Ltd.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K971695 · Fisher & Paykel Electronics , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
81d
Days
Class 2
Risk

K971695 is an FDA 510(k) clearance for the SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Fisher & Paykel Electronics , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on July 28, 1997 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fisher & Paykel Electronics , Ltd. devices

FDA 510(k) Submission Details - K971695

510(k) Number K971695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1997
Decision Date July 28, 1997
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
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 46
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K971695.
INCUWARMER
K971366 · Hill-Rom, Inc. · Jan 1998
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
K972885 · Fisher & Paykel Electronics , Ltd. · Oct 1997
BABYTHERM 8004 BABYTHERM 8010
K971198 · Drager, Inc. · Oct 1997
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
K971461 · Fisher & Paykel Electronics , Ltd. · Jul 1997
INFANT RADIANT WARMER - MODELS IW910 AND IW920
K970432 · Fisher & Paykel Electronics , Ltd. · May 1997
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
K970074 · Hill-Rom, Inc. · Apr 1997