Identifiers
- 510(k) Number
- K851892 FDA 510(k)
- FDA Product Code
- KDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6740 FDA 510(k)
- Regulation Number
- 880.6740 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Compact 2000 is a bottle, collection, vacuum, classified under the General Hospital specialty. It is designed as a medical device for collecting and storing blood or other bodily fluids under vacuum conditions, facilitating safe and efficient specimen handling in clinical settings.
This device is supplied as a single-use item and is intended for use in hospital environments. It is cleared under FDA 510(k) with the product code KDQ, following a Traditional review pathway. The Compact 2000 was authorized in 1985 and remains compliant with regulatory standards for vacuum collection bottles in general hospital applications.
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: K851892 FDA 510 (k) - COMPACT 2000 | Atrium Medical Corp., COMPACT 2000 (K851892) — FDA 510 (k) | Innolitics, PDF K851892 - Compact 2000, COMPACT 2000 510 (k) K851892 - FDA.report, COMPACT 2000 - Atrium Medical Corporation Trademark Registration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K851892 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrium Medical Corp.
Sources (1)
- FDA 510(k) K851892 24 fields · synced Oct 1, 2026