Cleared Traditional

K001019 - TI500 GLOBE-TROTTER TRANSPORT SYSTEM

K001019 is an FDA 510(k) clearance for TI500 GLOBE-TROTTER TRANSPORT SYSTEM, manufactured by Hill-Rom Air-Shields. The device is a Class 2 General Hospital device with product code FPL cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K001019 · Hill-Rom Air-Shields · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
28d
Days
Class 2
Risk

K001019 is an FDA 510(k) clearance for the TI500 GLOBE-TROTTER TRANSPORT SYSTEM. Classified as Incubator, Neonatal Transport (product code FPL), Class II - Special Controls.

Submitted by Hill-Rom Air-Shields (Hatboro, US). The FDA issued a Cleared decision on April 27, 2000 after a review of 28 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K001019

510(k) Number K001019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2000
Decision Date April 27, 2000
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FPL Incubator, Neonatal Transport

All 24
Devices cleared under the same product code (FPL) and FDA review panel - the closest regulatory comparables to K001019.
LMT NOMAG IC 1,5
K033565 · Lmt Lammers Medical Technology GmbH · Nov 2003
MODIFICATION TO TRANSPORT INCUBATOR 185
K031096 · International Biomedics, Inc. · Jun 2003
MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
K022876 · International Biomedical, Inc. · Sep 2002
MODEL TI500 ISOLETTE INFANT INCUBATOR
K941106 · Air-Shields, Inc. · Jun 1994
FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT
K932417 · Ferno-Washington, Inc. · Sep 1993
FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT
K931346 · Ferno · Aug 1993
K001019 · TI500 GLOBE-TROTTER TRANSPORT SYSTEM
Download PDF FDA Summary Hill-Rom Air-Shields