510(k) Report

Devices descending from K964312

10 later devices reach Mentor Tono-Pen 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053430Tono-Pen Avia Tonometer and Ocu-Shiled Tip CoverMedtronic Xomed, Inc.20069—
+2K063873Icare Tonometer TA01ITiolat OY20078—
+3K163343Icare HOME tonometerIcare Finland OY20172—
+3K153694Icare ic100Icare Finland OY20164—
+4K233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.20240—
+4K200966Icare HOME TonometerIcare Finland OY20201—
+4K190316Icare ic200Icare Finland OY20202—
+5K220852iCare IC200Icare Finland OY20221—
+5K211355iCare HOME2Icare Finland OY20220—
+6K241447iCare ST500 (TA04)Icare Finland OY20240—