510(k) Report

Devices descending from K042843

4 later devices reach Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…Flexicare Medical Limited.20180—
+1K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…Ambu A/S20161Class I
+1K094003RevivatorHersill, S.L.20100—
+2K243861butterflyBVMCompact Medical, Inc.20250—