Cleared Traditional

MEDIX PC-305 NEONATAL INCUBATOR (K920049) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920049 · Medix I.C.S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
501d
Days
Class 2
Risk

K920049 is an FDA 510(k) clearance for the MEDIX PC-305 NEONATAL INCUBATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Medix I.C.S.A. (San Martin, Buenos Aires, AR). The FDA issued a Cleared decision on May 21, 1993 after a review of 501 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Medix I.C.S.A. devices

Submission Details

510(k) Number K920049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1992
Decision Date May 21, 1993
Days to Decision 501 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
372d slower than avg
Panel avg: 129d · This submission: 501d
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 84
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K920049.
Babyleo TN500
K251619 · Dr?gerwerk AG & Co KGaA · Feb 2026
Giraffe OmniBed Carestation (CS1)
K251663 · Datex-Ohmeda, Inc. · Oct 2025
mOm Essential Incubator (ME1)
K243437 · Mom Incubators Limited · Aug 2025
Giraffe Incubator Carestation CS1
K213553 · Datex-Ohmeda, Inc. · Mar 2022
Infant Incubator
K190494 · Ningbo David Medical Device Co., Ltd. · Nov 2019
Babyleo TN500
K182859 · Dragerwerk AG & CO Kgaa · Feb 2019