Cleared Traditional

K881476 - PREEMICARE MODEL D1-X1, SERIES 3000

K881476 is an FDA 510(k) clearance for PREEMICARE MODEL D1-X1, manufactured by Preemicare Corp.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K881476

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.

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 63
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K881476.
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OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
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OHMEDA - OHIO(R) CARE PLUS INCUBATOR
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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