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510(k) K172154

Isolette 8000 plus by Draeger Medical Sytems, Inc. — Product Code FMZ

K172154 is an FDA 510(k) premarket notification submitted by Draeger Medical Sytems, Inc. for the device "Isolette 8000 plus". The FDA issued a decision of Substantially Equivalent on April 19, 2018. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Draeger Medical Sytems, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2018
Date Received
July 17, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

Other clearances by Draeger Medical Sytems, Inc.

  • K152407 — Infinity Delta, Infinity Delta XL, Infinity Kappa (September 23, 2015)

Other clearances for product code FMZ

  • K251619 — Babyleo TN500 (February 13, 2026)
  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • K243437 — mOm Essential Incubator (ME1) (August 14, 2025)
  • K213553 — Giraffe Incubator Carestation CS1 (March 2, 2022)
  • K190494 — Infant Incubator (November 25, 2019)
  • K182859 — Babyleo TN500 (February 22, 2019)
  • K182977 — Isolette 8000 Plus (November 21, 2018)
  • K162821 — Babyleo TN500 (June 23, 2017)
  • K152814 — Giraffe OmniBed Carestation CS1 (March 17, 2016)
  • K152809 — Giraffe Incubator Carestation CS1 (December 31, 2015)

FDA data resources