EWL · Class II · 21 CFR 874.3730

FDA Product Code EWL: Prosthesis, Laryngeal (taub)

Leading manufacturers include Bivona Medical Technologies, American V. Mueller and Xomed, Inc..

40
Total
40
Cleared
112d
Avg days
1980
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 273d recently vs 108d historically

FDA 510(k) Cleared Prosthesis, Laryngeal (taub) Devices (Product Code EWL)

40 devices
1–24 of 40
Cleared Dec 18, 2024
FirstFit Surgical Kit
K240763
Freudenberg Medical, LLC
Ear, Nose, Throat · 273d
Cleared Sep 04, 1992
SINGH SPEECH SYSTEM (SERIES 'SSS')
K912486
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 458d
Cleared Jun 29, 1992
BIVONA-COLORADO VOICE PROSTHESIS
K915761
Bivona Medical Technologies
Ear, Nose, Throat · 188d
Cleared May 13, 1988
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS
K881011
Bivona Medical Technologies
Ear, Nose, Throat · 64d
Cleared Jun 08, 1987
ESKA-HERRMANN TRACHEOSTOMY VALVE
K871885
C.R. Bard, Inc.
Ear, Nose, Throat · 25d
Cleared Apr 02, 1986
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
K861088
Bivona Medical Technologies
Ear, Nose, Throat · 12d
Cleared Aug 17, 1984
BLOM-SINGER LOW PRESSURE VOICE PROSTHES
K842896
American V. Mueller
Ear, Nose, Throat · 25d
Cleared Dec 23, 1983
DUCKBILL VOICE PROSTHESIS & TRACHEO
K832967
American V. Mueller
Ear, Nose, Throat · 113d
Cleared Sep 29, 1983
BLAISE-RATHAEL VOICE PROSTHESIS
K832852
Richards Medical Co., Inc.
Ear, Nose, Throat · 44d
Cleared Jan 07, 1983
LOW PRESSURE BLOM-SINGER VOICE PROSTHES
K823749
Bivona Medical Technologies
Ear, Nose, Throat · 25d
Cleared Jul 26, 1982
BLOW-SINGER TRACHEOSTOMA VALVE
K821568
Bivona Medical Technologies
Ear, Nose, Throat · 60d
Cleared Apr 09, 1982
PERISCOPE VOICE PROSTHESIS
K820737
Bivona Medical Technologies
Ear, Nose, Throat · 22d
Cleared Nov 24, 1981
SILASTIC VOICE PROSTHESIS
K812864
Dow Corning Corp. Healthcare Industries Materials
Ear, Nose, Throat · 42d
Cleared Nov 24, 1981
BLOM-SINGER VOICE PROSTHESIS
K812982
Bivona Medical Technologies
Ear, Nose, Throat · 32d
Cleared Feb 05, 1981
PANJE VOICE PROSTHESIS
K810020
Xomed, Inc.
Ear, Nose, Throat · 31d
Cleared Mar 25, 1980
BLOM-SINGER DUCKBILL VOICE PROSTHESIS
K800563
Bivona Medical Technologies
Ear, Nose, Throat · 12d

About Product Code EWL - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code EWL since 1980, with 40 receiving FDA clearance (average review time: 112 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - EWL Product Code

Recent submissions under EWL have taken an average of 273 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.

EWL devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →