Hygia Health Services Reprocessed Oximax Sensors Model # Hhs-Max-a, Hhs-Max-Al, Hhs-Max-N

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K041867 ↗

FDA Product Code

NLF

Models / Variants

# Hhs-Max-A

Hhs-Max-Al

Hhs-Max-N

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Hygia Health Services, Inc. →

• Are these reprocessed oximeter sensors designed for reuse in multiple patients, and if so, how is that achieved?

  No, these sensors are not intended for direct reuse across multiple patients in their original form. Instead, they are reprocessed by Hygia Health Services, Inc. to be single-use after reprocessing, meaning each sensor is sterilized and prepared for one clinical use following the reprocessing cycle. The reprocessing ensures they meet sterility standards for safe patient application.

• What patient populations are these sensors intended for, and how do the models differ?

  The sensors are available in three models tailored to specific patient populations: HHS-MAX-A for adults, HHS-MAX-AL for pediatric patients, and HHS-MAX-N for infants. The sizing and design of each model are optimized for accurate monitoring of blood oxygen saturation (SpO₂) and pulse rate in the respective age groups, ensuring proper fit and measurement reliability.

• How should these reprocessed sensors be stored to maintain sterility and functionality?

  These sensors must be stored strictly according to reprocessing and sterility protocols outlined by Hygia Health Services, Inc. to ensure they remain sterile and functional for clinical use. Improper storage could compromise sterility or performance, so adherence to manufacturer guidelines is critical before use.

• What is the regulatory pathway for these reprocessed oximeter sensors, and how does it differ from traditional single-use devices?

  These sensors follow the FDA 510(k) clearance pathway (K041867) under regulation number 870.2700, confirming they are substantially equivalent to a predicate device. Unlike traditional single-use sensors, they undergo reprocessing (cleaning, sterilization, and inspection) by Hygia Health Services, Inc. to be reused once, ensuring compliance with FDA requirements for reprocessed medical devices.

• Can these sensors be used with any pulse oximeter system, or are they compatible only with specific devices?

  The provided data does not specify compatibility with particular pulse oximeter systems, so it cannot be confirmed whether these sensors are designed exclusively for certain devices. However, as they are reprocessed oximeter sensors, they are intended to function with standard pulse oximetry equipment that utilizes fingertip, toe, or foot-based measurements for SpO₂ and pulse rate monitoring.