Identifiers
- 510(k) Number
- K925446 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bard Safe Sampling Device is a medical device designed for sampling purposes. It is identified by the device name Bard Safe Sampling Device and product code FMI.
The device received FDA 510(k) clearance under K925446 on July 29, 1993, and is manufactured by C.R. Bard, Inc. It is classified under the General Hospital advisory committee (HO) and was cleared via the traditional 510(k) pathway.
Frequently asked questions
What is the Bard Safe Sampling Device used for?
The Bard Safe Sampling Device is designed for sampling purposes in a general hospital setting, as indicated by its classification under the General Hospital advisory committee (HO) and its intended use for collecting samples.
How is the Bard Safe Sampling Device identified and regulated?
The device is identified by the name Bard Safe Sampling Device and product code FMI, and it received FDA 510(k) clearance under K925446 on July 29, 1993, through the traditional pathway as substantially equivalent to a predicate device.
Who manufactures the Bard Safe Sampling Device and where is it made?
The Bard Safe Sampling Device is manufactured by C.R. Bard, Inc., with the applicant listed as C.R. Bard, Inc., and the device associated with their facility in Covington, Georgia, United States.
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: BARD SAFE SAMPLING DEVICE (K925446) — FDA 510(k) | Innolitics, BARD SAFE SAMPLING DEVICE (K925446) - FDA 510 (k), Establishment Registration & Device Listing, C.R. Bard, Inc. FDA 510 (k) Products - Latest 2026
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K925446 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K925446 24 fields · synced Sep 25, 2026