EWL · Class II · 21 CFR 874.3730

FDA Product Code EWL: Prosthesis, Laryngeal (taub)

Leading manufacturers include Bivona Medical Technologies, Atos Medical AB and Helix Medical, LLC.

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 26, 2014
PROVOX FREEHANDS FLEXIVOICE
K141380
Atos Medical AB
Ear, Nose, Throat · 122d
Cleared Oct 18, 2013
PROVOX VEGA PUNCTURE SET
K131947
Atos Medical AB
Ear, Nose, Throat · 113d
Cleared Oct 14, 2010
PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)
K092593
Atos Medical AB
Ear, Nose, Throat · 416d
Cleared Mar 03, 2010
BLOM-SINGER INDWELLING TEP OCCLUDER
K093258
Helix Medical, LLC
Ear, Nose, Throat · 135d
Cleared Jun 05, 2009
PROVOX VEGA, MODEL 8130-8135
K090455
Atos Medical AB
Ear, Nose, Throat · 102d
Cleared Sep 04, 2008
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
K082206
Helix Medical, LLC
Ear, Nose, Throat · 30d
Cleared Nov 22, 2004
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
K043138
Atos Medical AB
Ear, Nose, Throat · 10d
Cleared Jun 25, 1999
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
K991587
Helix Medical, Inc.
Ear, Nose, Throat · 49d
Cleared Feb 25, 1998
VOICE MASTER PROSTHESIS
K974132
E. Benson Hood Lab, Inc.
Ear, Nose, Throat · 114d
Cleared Jun 06, 1997
PROVOX 2 VOICE PROSTHESIS SYSTEM
K971244
Atos Medical AB
Ear, Nose, Throat · 64d
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 Mar 17, 1986
DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS
K854118
Dacomed Corp.
Ear, Nose, Throat · 159d
Cleared Mar 12, 1986
FLEXIBLE GRASPING FORCEPS
K854112
Hood Laboratories
Ear, Nose, Throat · 155d
Cleared Dec 13, 1985
THE GRONINGEN VOICE PROSTHESIS
K853940
Hood Laboratories
Ear, Nose, Throat · 80d
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

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 →