Cleared Traditional

K881476 - PREEMICARE MODEL D1-X1

K881476 is the FDA 510(k) clearance for PREEMICARE MODEL D1-X1 by Preemicare Corp.. It is a Class 2 General Hospital device (product code FMZ) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K881476 · Preemicare Corp. · General Hospital
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Dec 1988
Decision
245d
Days
Class 2
Risk

K881476 is an FDA 510(k) clearance for the PREEMICARE MODEL D1-X1, SERIES 3000. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Preemicare Corp. (Houston, US). The FDA issued a Cleared decision on December 8, 1988 after a review of 245 days - an extended review cycle.

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 Preemicare Corp. devices

Submission Details

510(k) Number K881476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1988
Decision Date December 08, 1988
Days to Decision 245 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
116d slower than avg
Panel avg: 129d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K881476.
OHIO CARE PLUS INCUBATOR
K914487 · Ohmeda Medical · Dec 1991
OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
K913154 · Ohmeda Medical · Sep 1991
OHMEDA - OHIO(R) CARE PLUS INCUBATOR
K901585 · Ohmeda Medical · Jun 1990
AMEDA AMECARE(R) NEONATAL INCUBATOR
K870222 · Hollister, Inc. · Jun 1987
AMEDA AMELETTE(R) NEONATAL INCUBATOR
K870223 · Hollister, Inc. · Jun 1987
OHIO(R) CARE PLUS INCUBATOR
K871399 · Ohmeda Medical · Jun 1987