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UPH-2000 Universal Oximetry Probe Holder

FDA 510(k)

Class II (US FDA 510(k))

510(k) K914538

by Innovative Medical Products, Inc.

Identifiers

510(k) Number
K914538 FDA 510(k)
FDA Product Code
DQA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The UPH-2000 Universal Oximetry Probe Holder is a device designed to securely hold and position pulse oximetry probes during clinical use. It facilitates accurate and stable monitoring of patient oxygen saturation levels by maintaining consistent probe placement, reducing movement artifacts and ensuring reliable readings in various patient care settings.

This device is intended for single-use applications and is classified under product code DQA. It requires no special storage conditions and is supplied sterile for immediate clinical use. The UPH-2000 has received FDA 510(k) clearance under the Traditional pathway, with a decision date of July 14, 1992, and is categorized under the Cardiovascular advisory committee.

Frequently asked questions

What clinical scenarios would the UPH-2000 Universal Oximetry Probe Holder be most useful in, and why?

The UPH-2000 is designed to improve pulse oximetry accuracy in settings where probe movement—such as during patient transport, ambulation, or restless sleep—could otherwise cause unreliable readings. Its secure, stable positioning minimizes artifacts from shifting, making it ideal for critical care units, emergency departments, operating rooms, or any environment where continuous, accurate oxygen saturation monitoring is critical. The holder’s universal design ensures compatibility with standard oximetry probes, reducing the need for specialized adapters.

Is the UPH-2000 intended for reuse, or does it require disposal after a single use?

The UPH-2000 is explicitly designed for single-use only, as stated in its description. This classification aligns with clinical best practices for maintaining sterility and hygiene, particularly in pulse oximetry applications where contamination risks could compromise patient safety. Each unit is supplied sterile and intended for immediate use in one patient encounter.

How should the UPH-2000 be stored before use, and are there any special handling requirements?

The device requires no special storage conditions—it can be kept at standard room temperature until ready for use. Since it is supplied sterile and intended for single-use, there’s no need for refrigeration or protective packaging beyond what’s provided. Clinicians should ensure the sterile barrier remains intact until the time of use to maintain sterility.

What regulatory pathway was followed for FDA clearance of the UPH-2000, and how does that affect its use?

The UPH-2000 received FDA 510(k) clearance under the Traditional pathway (decision date: July 14, 1992) and was determined to be substantially equivalent to a predicate device. This means it meets the agency’s requirements for safety and effectiveness as established by prior devices in the same category (product code DQA). Clinically, this clearance confirms its suitability for secure oximetry probe positioning, but users should always follow facility protocols for device integration and maintenance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER (K914538) — FDA 510 (k ..., Uph-2000 Universal Oximetry Probe Holder - Beudamed, Innovative Medical Products, Inc. · DeviceClearance, INNOVATIVE MEDICAL PRODUCTS, INC. - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K914538 24 fields · synced Sep 19, 2026