Atlas FDA

FPL

25 FDA 510(k) clearances · Product code

104 daysmedian time to decision
161 days90th percentile
25clearances measured

FDA profile

Official device name
Incubator, Neonatal Transport
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5410
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 2 · 2001: 2 · 2002: 2 · 2003: 2 · 2005: 2 · 2010: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
NxtGen Infant Transport Incubator (K220742)International Biomedical2022-07-15
SREE MRI Transport Incubator (K161918)Advanced Imaging Research Dba Sree Medical Systems2017-03-03
GLOBE-TROTTER GT5400 (K141565)Draeger Medical Systems, Inc.2014-09-10
ATOM TRANSCAPSULE V-707 (K123937)Atom Medical Corporation2013-05-23
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX (K103525)International Biomedical, Ltd.2011-05-11
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX (K103523)International Biomedical, Ltd.2011-05-11
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX (K103524)International Biomedical, Ltd.2011-04-15
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX (K103527)International Biomedical, Ltd.2011-04-15
AVIATOR TRANSPORT INCUBATOR (K081399)International Biomedical, Ltd.2008-06-06
V-808 ATOM TRANSCAPSULE (K061071)Atom Medical, Inc.2006-08-29
LMT NOMAG IC 3.0 (K062052)Lmt Lammers Medical Technology GmbH2006-07-31
LMT NOMAG IC 1,5 (K033565)Lmt Lammers Medical Technology GmbH2003-11-21
MODIFICATION TO TRANSPORT INCUBATOR 185 (K031096)International Biomedics, Inc.2003-06-24
MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 (K022876)International Biomedical, Inc.2002-09-11
TI500 GLOBE-TROTTER TRANSPORT SYSTEM (K001019)Hill-Rom Air-Shields2000-04-27
MODEL TI500 ISOLETTE INFANT INCUBATOR (K941106)Air-Shields, Inc.1994-06-10
FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT (K932417)Ferno-Washington, Inc.1993-09-09
FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT (K931346)Ferno1993-08-25
PREEMICARE MODEL 2500 TRANSPORT WARMER (K893624)Preemicare Corp.1989-09-27
INFANT LIFE SUPPORT MODULE-20 (K854065)Intl. Biomedics, Inc.1986-01-16
TRANSPORT INCUBATOR 185 (K850496)Airborne Life Support Systems, Inc.1985-05-23
TI-1000 TRANSPORT INCUBATOR (K831028)Narco Scientific1983-05-09
REVISED BATTERY CHARGER (K790689)Vickers America Medical Corp.1979-05-29
TRANSPORT INCUBATOR (K790551)Narco Air-Shields1979-04-24
TRANSPORT INCUBATOR (K780964)Cavitron Corp.1978-07-27

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Every clearance here is in the API, with alerts when new ones post.