Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor— 510(k) K253033
Substantially EquivalentSimplivia Healthcare , Ltd.
FDA 510(k) clearance K253033 for Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor, Substantially Equivalent on 2025-10-21. Applicant: Simplivia Healthcare , Ltd.. Device class: 2.
Clearance details
- Applicant
- Simplivia Healthcare , Ltd.
- Product code
- Code ONB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kiryat Shmona, IL
Recent devices under product code ONB
view allMore clearances from Simplivia Healthcare , Ltd.
view all- K231286 — Chemfort® Catheter Adaptor
- K210707 — OnGuard2 Chemfort Closed Administration (CADM)
- K201142 — TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set
- K192866 — Chemfort CSTD
Adverse events under product code ONB
product code ONB- Malfunction
- 3,615
- Other
- 13
- Total
- 3,628
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.