Oxford Human Milk Pasteuriser

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

510(k) Number

K801246 ↗

FDA Product Code

HGX

Device Class

Class II

Regulation

21 CFR Part 884.5160

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Sp 120 Sophisticate

  Class I

  FDA 510(k) K802251 Active Cleared 23 Oct 1980

• Neocare Baby-Controlled Incubator

  Class II

  FDA 510(k) K813238 Active Cleared 22 Jan 1982

• Treonic IP5

  Class II

  FDA 510(k) K830936 Active Cleared 12 Apr 1983

• Peep/Cpap Valve

  Class II

  FDA 510(k) K781332 Active Cleared 4 Oct 1978

• Laboratory Data Mgmt System Sdms

  Class I

  FDA 510(k) K831838 Active Cleared 24 Jan 1984

• Resuscitaire

  Class II

  FDA 510(k) K830748 Active Cleared 22 Jun 1983

See all devices from Vickers America Medical Corp. →

• What is the Oxford Human Milk Pasteuriser used for?

  The Oxford Human Milk Pasteuriser is designed specifically for heat-treating donated human milk in neonatal care settings. It uses automated heating and cooling to safely pasteurise milk, reducing bacterial contamination while maintaining the nutritional integrity of the milk for infants requiring donor feedings in special care units.

• How long does a typical pasteurisation cycle take with this device?

  Each pasteurisation cycle on the Oxford Human Milk Pasteuriser takes approximately 100 minutes, including preparation, heating, and cooling phases. This ensures thorough processing while maintaining efficiency in clinical environments.

• Is the Oxford Human Milk Pasteuriser single-use or reusable?

  The device can be supplied as either single-use or reusable, as indicated in regulatory filings. The choice depends on facility protocols and infection control requirements, though reusable systems must adhere to strict cleaning and sterilisation standards for neonatal use.

• What regulatory pathway does the Oxford Human Milk Pasteuriser follow?

  The device was cleared under the FDA’s 510(k) pathway, specifically classified under obstetrics/gynecology applications. It was deemed substantially equivalent to a predicate device, ensuring compliance with medical-grade processing standards for neonatal care.

• Does the device have any specific storage or handling requirements?

  While the device itself does not specify MRI safety or sterility classifications, its use in neonatal units mandates adherence to infection control protocols. Facilities must follow manufacturer guidelines for cleaning, maintenance, and storage to ensure safe and effective operation in clinical environments.