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510(k) K890476

ADEL - MODEL 986 INFANT WARMER by Adel Medical , Ltd. — Product Code FMZ

K890476 is an FDA 510(k) premarket notification submitted by Adel Medical , Ltd. for the device "ADEL - MODEL 986 INFANT WARMER". The FDA issued a decision of Substantially Equivalent on June 16, 1989. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Adel Medical , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1989
Date Received
January 31, 1989
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 Adel Medical , Ltd.

  • K874610 — ADEL MODEL 2100 BIRTHING BED (January 21, 1988)
  • K871475 — SOLOLIFT - PATIENT TRANSFER STRETCHER (May 11, 1987)
  • K861030 — LABOR-DELIVERY STRETCH/BED (April 23, 1986)
  • K860020 — MINOR SURGERY LIGHT MODEL 2112 (January 24, 1986)
  • K833321 — LABOR/DELIVERY/RECOVERY BED LDR-600 (November 14, 1983)
  • K810886 — ADEL MEDICAL BIRTHING BED, #LD-500 (April 23, 1981)
  • K801622 — ADEL MEDICAL BIRTHING BED, MOD. LD-400 (August 14, 1980)

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)
  • K172154 — Isolette 8000 plus (April 19, 2018)
  • K162821 — Babyleo TN500 (June 23, 2017)
  • K152814 — Giraffe OmniBed Carestation CS1 (March 17, 2016)

FDA data resources