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510(k) K122370

CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR by Bayer Healthcare — Product Code NBW

K122370 is an FDA 510(k) premarket notification submitted by Bayer Healthcare for the device "CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR". The FDA issued a decision of Substantially Equivalent on September 26, 2013. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Bayer Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2013
Date Received
August 6, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Bayer Healthcare

  • K171802 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (March 7, 2018)
  • K152852 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (December 22, 2015)
  • K150942 — Contour Next USB Blood Glucose Monitoring System (November 25, 2015)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METER (June 23, 2014)
  • K121190 — CONTOUR NEXT BLOOD GLUCOSE METER (July 26, 2012)
  • K121087 — CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM (June 28, 2012)
  • K110894 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER (March 28, 2012)
  • K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CON (March 28, 2012)
  • K111268 — CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM (March 6, 2012)

Other clearances for product code NBW

  • K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK (October 10, 2025)
  • K243060 — TeleRPM Gen2 Blood Glucose Monitoring System (January 30, 2025)
  • K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel (November 4, 2024)
  • K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitori (October 8, 2024)
  • K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Gluc (August 27, 2024)
  • K222126 — VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose (August 16, 2024)
  • K241304 — WaveSense Jazz Blood Glucose Monitoring System (June 6, 2024)
  • K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System (February 23, 2024)
  • K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel (January 19, 2024)
  • K233058 — VivaChek Link Plus Blood Glucose Monitoring System (December 22, 2023)

FDA data resources