Product code FPL— General Hospital
TRANSPORT INCUBATOR
- Classification name
- Incubator, Neonatal Transport
- Device class
- Class 2
- Regulation
- 21 CFR 880.5410
- Advisory panel
- General Hospital
- Total cleared
- 25
- First cleared
- Most recent
Market context for product code FPL
FDA has cleared devices under product code FPL between 1978 and 2022, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2017
- 2014
- 2013
- 2011
- 2008
- 2006
- 2003
- 2002
- 2000
- 1994
- 1993
- 1989
- 1986
- 1985
Top applicants under product code FPL
Recent clearances under product code FPL
- K220742 — NxtGen Infant Transport Incubator
- K161918 — SREE MRI Transport Incubator
- K141565 — GLOBE-TROTTER GT5400
- K123937 — ATOM TRANSCAPSULE V-707
- K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
- K103525 — A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
- K103524 — VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
- K103527 — AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
- K081399 — AVIATOR TRANSPORT INCUBATOR
- K061071 — V-808 ATOM TRANSCAPSULE
- K062052 — LMT NOMAG IC 3.0
- K033565 — LMT NOMAG IC 1,5
- K031096 — MODIFICATION TO TRANSPORT INCUBATOR 185
- K022876 — MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
- K001019 — TI500 GLOBE-TROTTER TRANSPORT SYSTEM
- K941106 — MODEL TI500 ISOLETTE INFANT INCUBATOR
- K932417 — FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT
- K931346 — FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT
- K893624 — PREEMICARE MODEL 2500 TRANSPORT WARMER
- K854065 — INFANT LIFE SUPPORT MODULE-20
- K850496 — TRANSPORT INCUBATOR 185
- K831028 — TI-1000 TRANSPORT INCUBATOR
- K790689 — REVISED BATTERY CHARGER
- K790551 — TRANSPORT INCUBATOR
- K780964 — TRANSPORT INCUBATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.