Contour® next GEN Blood Glucose Monitoring System— 510(k) K193407
Substantially EquivalentAscensia Diabetes Care
FDA 510(k) clearance K193407 for Contour® next GEN Blood Glucose Monitoring System, Substantially Equivalent on 2021-12-23. Applicant: Ascensia Diabetes Care. Device class: 2.
Clearance details
- Applicant
- Ascensia Diabetes Care
- Product code
- Code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valhalla, NY, US
Recent devices under product code NBW
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- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
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More clearances from Ascensia Diabetes Care
view all- K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System
- K210687 — CONTOUR® NEXT ONE Blood Glucose Monitoring System
- K191286 — CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System
- K160682 — CONTOUR NEXT ONE Blood Glucose Monitoring System
Adverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
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 →
Recalls naming K193407
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193407.
Data sourced from openFDA. This site is unofficial and independent of the FDA.