BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets— 510(k) K223243
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K223243 for BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets, Substantially Equivalent on 2022-12-16. Applicant: Becton, Dickinson and Company. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Code FMK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Recent devices under product code FMK
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- K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
- K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
- K260184 — Onclarity Self-Collection Kit
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
Adverse events under product code FMK
product code FMK- Injury
- 133
- Malfunction
- 1,278
- Other
- 1
- Total
- 1,412
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.