Cleared Abbreviated

LMT NOMAG IC 1,5 (K033565) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K033565 · Lmt Lammers Medical Technology GmbH · General Hospital
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Nov 2003
Decision
9d
Days
Class 2
Risk

K033565 is an FDA 510(k) clearance for the LMT NOMAG IC 1,5. Classified as Incubator, Neonatal Transport (product code FPL), Class II - Special Controls.

Submitted by Lmt Lammers Medical Technology GmbH (Luebeck, DE). The FDA issued a Cleared decision on November 21, 2003 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5410 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Lmt Lammers Medical Technology GmbH devices

Submission Details

510(k) Number K033565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2003
Decision Date November 21, 2003
Days to Decision 9 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 129d · This submission: 9d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code FPL Incubator, Neonatal Transport
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5410
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.