Cleared Abbreviated

K033565 - LMT NOMAG IC 1,5

K033565 is an FDA 510(k) clearance for LMT NOMAG IC 1, manufactured by Lmt Lammers Medical Technology GmbH. The device is a Class 2 General Hospital device with product code FPL cleared through the Abbreviated 510(k) pathway after a 9-day FDA review.

K033565 · Lmt Lammers Medical Technology GmbH · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K033565

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
Combination Product No
PCCP Authorized No
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.

FPL Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Underwriters Laboratories, Inc.
SUSAN A GILL

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FPL Incubator, Neonatal Transport

All 23
Devices cleared under the same product code (FPL) and FDA review panel - the closest regulatory comparables to K033565.
AVIATOR TRANSPORT INCUBATOR
K081399 · International Biomedical, Ltd. · Jun 2008
V-808 ATOM TRANSCAPSULE
K061071 · Atom Medical, Inc. · Aug 2006
LMT NOMAG IC 3.0
K062052 · Lmt Lammers Medical Technology GmbH · Jul 2006
MODIFICATION TO TRANSPORT INCUBATOR 185
K031096 · International Biomedics, Inc. · Jun 2003
MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
K022876 · International Biomedical, Inc. · Sep 2002
TI500 GLOBE-TROTTER TRANSPORT SYSTEM
K001019 · Hill-Rom Air-Shields · Apr 2000

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K033565 · LMT NOMAG IC 1,5
Download PDF FDA Summary Lmt Lammers Medical T…