Adel Model 986 Infant Warmer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K890476 ↗

FDA Product Code

FMZ

FDA applicant

Adel Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 880.5400

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K810886 Active Cleared 23 Apr 1981

• Labor-Delivery Stretch/Bed

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  Class I

  FDA 510(k) K871475 Active Cleared 11 May 1987

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• Adel Model 2100 Birthing Bed

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• Adel Medical Birthing Bed, Mod. Ld-400

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  FDA 510(k) K801622 Active Cleared 14 Aug 1980

See all devices from Adel Medical, Ltd. →

• What is the Adel Model 986 Infant Warmer used for?

  The Adel Model 986 Infant Warmer is a neonatal incubator designed to provide a controlled thermal environment for infants requiring medical care, intended for use in general hospital settings to maintain stable body temperature during treatment.

• Is the Adel Model 986 Infant Warmer reusable or single-use?

  The Adel Model 986 Infant Warmer is supplied as a reusable unit, meaning it is designed for multiple uses after appropriate cleaning and maintenance between each patient use to ensure safety and functionality.

• How is the Adel Model 986 Infant Warmer supplied and what maintenance is required?

  The device is supplied as a reusable neonatal incubator that requires appropriate cleaning and maintenance between uses to ensure proper function and infection control, as specified in its labeling for general hospital use.

• What regulatory pathway was used for the Adel Model 986 Infant Warmer?

  The Adel Model 986 Infant Warmer was cleared through the FDA 510(k) process under submission K890476, demonstrating substantial equivalence to a legally marketed predicate device under product code FMZ and regulation number 880.5400.

• What is the device classification and product code for the Adel Model 986 Infant Warmer?

  The Adel Model 986 Infant Warmer is classified as a Class II medical device with product code FMZ, corresponding to a neonatal incubator under FDA regulation 880.5400 for general hospital use.