Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
K180574 is the FDA 510(k) clearance record for Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor, a class II device, cleared for J & J Solutions, Inc. D/B/A/ Corvida Medical on under FDA product code ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System). FDA's definition for product code ONB reads: "Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting". FDA records list 2 510(k) clearances for J & J Solutions, Inc. D/B/A/ Corvida Medical, from to . As of , FDA records show no recalls naming K180574.
Clearance record
- Decision date
- Received
- (165 days to decision)
- Product code
- ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Regulation
- 21 CFR 880.5440
- Device class
- Class II
- Review panel
- General Hospital
- Applicant
- J & J Solutions, Inc. D/B/A/ Corvida Medical 2945 Lone Oak Dr., Suite 150, Eagan MN
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code ONB
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 1 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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