Cleared Traditional

K960980 - ISOLETTE INFANT INCUBATOR

K960980 is an FDA 510(k) clearance for ISOLETTE INFANT INCUBATOR, manufactured by Air-Shields, Inc.. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K960980 · Air-Shields, Inc. · General Hospital
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Jul 1996
Decision
141d
Days
Class 2
Risk

K960980 is an FDA 510(k) clearance for the ISOLETTE INFANT INCUBATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Air-Shields, Inc. (Hatboro, US). The FDA issued a Cleared decision on July 30, 1996 after a review of 141 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5400 - 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 Air-Shields, Inc. devices

FDA 510(k) Submission Details - K960980

510(k) Number K960980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date July 30, 1996
Days to Decision 141 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 129d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMZ Device Classification - Class 2, Special Controls

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
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 - FMZ Incubator, Neonatal

All 41
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K960980.
BABYTHERM 8000 LDR
K980886 · Draeger Medical, Inc. · May 1998
OHMEDA-OHIO CARE PLUS INCUBATOR
K974349 · Ohmeda Medical · Feb 1998
OHMEDA-OHIO CAE PLUS INCUBATOR
K962806 · Ohmeda Medical · Sep 1996
OHIO CARE PLUS INCUBATOR
K943360 · Ohmeda Medical · Sep 1994
C450/C400 INFANT INCUBATORS
K940975 · Air-Shields, Inc. · Jun 1994
ISOLETTE INCUBATOR HUMIDITY METER
K924170 · Air-Shields, Inc. · Feb 1993