Minimus I; Minimus III, Sanaphon
510(k) K942649
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942649 | Date29 Nov 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Minimus I; Minimus III, Sanaphon are aneroid sphygmomanometers designed for measuring blood pressure. These devices fall under the cardiovascular category and are intended for clinical use in assessing arterial blood pressure in patients. The Minimus I and Minimus III models feature a twin-tube design, providing accurate and reliable readings essential for cardiovascular monitoring and diagnosis.
These sphygmomanometers are portable, reusable devices supplied with a metal construction and corrosion-resistant materials. The Minimus III model includes a chromium-plated screwed tube connector and an ergonomic spoon-shaped grip for ease of use. They are classified under FDA product code DXN and have received a Traditional 510(k) clearance under the FDA’s cardiovascular review pathway, with a decision date of November 29, 1994. No specific sterility or MRI safety information is provided in the data.
Other devices from Rud Riester GmbH & CO KG
Questions
AI-generated answers, 1 Oct 2026
What is the Minimus I; Minimus III, Sanaphon used for?
The Minimus I and Minimus III, Sanaphon are aneroid sphygmomanometers designed specifically for measuring arterial blood pressure in patients. They fall under the cardiovascular category and are intended for clinical use, providing reliable readings essential for cardiovascular monitoring and diagnosis. The twin-tube design ensures precision, making them suitable for routine patient assessments.
How is the Minimus III supplied and what materials are used?
The Minimus III is supplied as a portable, reusable device with a metal construction. It features corrosion-resistant materials for durability and includes a chromium-plated screwed tube connector. The ergonomic spoon-shaped grip enhances ease of use, making it practical for clinical environments where portability and reliability are important.
Is the Minimus I or III single-use or reusable?
Both the Minimus I and Minimus III are reusable devices. They are designed for repeated use in clinical settings, provided they are properly maintained and cleaned according to standard medical device protocols. No specific sterility information is provided, so adherence to facility-specific decontamination procedures is recommended.
What distinguishes the Minimus III from the Minimus I?
The Minimus III includes additional features not mentioned for the Minimus I, such as a chromium-plated screwed tube connector and an ergonomic spoon-shaped grip. While both models share the twin-tube design for accurate blood pressure measurement, the Minimus III’s enhanced grip and connector likely improve usability and longevity in clinical environments.
What regulatory pathway was followed for FDA clearance?
The Minimus I; Minimus III, Sanaphon received a Traditional 510(k) clearance under the FDA’s cardiovascular review pathway. The decision was made by the Cardiovascular (CV) Advisory Committee, and the device was deemed substantially equivalent to a predicate product. The clearance date was November 29, 1994, with the product classified under FDA product code DXN.