510(k) Report

Devices descending from K042682

5 later devices reach Ambu Spur II. Adult Single Patient Resuscitator 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—
+1K093081Pocket BVMMicrobvm Systems, Ltd.20100—
+2K243861butterflyBVMCompact Medical, Inc.20250—