BD Recykleen Sharps Collectors
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112774 FDA 510(k)
- FDA Product Code
- MMK 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 BD Recykleen Sharps Collectors are single-use containers designed for the safe disposal of contaminated medical sharps. These devices fall under the category of sharps disposal containers, providing a secure method to manage and contain hazardous waste in healthcare settings to prevent needlestick injuries and ensure compliance with safety protocols.
These containers are supplied in multiple sizes, including 5.4 quart, 2-gallon, and 3-gallon variants, and are intended for single-use in healthcare facilities. They are non-sterile, reusable in terms of cabinet use (not the container itself), and are classified as Class II devices under FDA regulations. The containers are part of a registered system with the FDA (K112774) and are intended for general hospital use, adhering to regulatory standards for sharps disposal.
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: BD® Sharps Disposal, BD Recykleen™ Sharps Container Locking Wall Cabinet, 5.4 qt, patient ..., BD RECYKLEEN SHARPS COLLECTORS (K112774) — FDA 510 (k) | Innolitics, BD (company) - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112774 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K112774 24 fields · synced Sep 18, 2026