510(k) Report

Devices descending from K860105

9 later devices reach Spiral-Flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192324Sheridan Spiral-Flex Endotracheal TubesTeleflexmedical, Inc.20190—
+1K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd.20056—
+1K954585Rusch Pediatric Reinforced Traheal (or Endotracheal) Tube - Uncuffed, SterileRusch Intl.19960—
+2K242495LMA Fastrach ETT SUTeleflex Medical20250—
+2K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd.20144—
+3K142103Cuff Pilot, Sure SealTeleflexmedical, Inc.20153—
+4K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.20190—
+4K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd.20171—
+5K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd.20190—