# K082206: Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 Series

- Pathway: 510(k) (Special)
- Applicant: Helix Medical, LLC
- Decided: Sep 4, 2008 after 30 days
- Product code: EWL (Prosthesis, Laryngeal (Taub))
- Device class: 2
- Regulation: 21 CFR 874.3730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930105 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932120: Blom-Singer Indwelling Low Pressure Voice Prosthes, Helix Medical, Inc. (1994) Summary page 1.
- K945287: Inhealth Blom-Singer Indwelling Valved Insert Accessory Device, Helix Medical, Inc. (1994) Summary page 1.
- K991587: Blom-Singer Indwelling 2000 Voice Prosthesis, Helix Medical, Inc. (1999) Summary page 1.

## Indications for use
The Blom-Singer Indwelling voice prosthesis is indicated for tracheoesophageal voice restoration following total laryngectomy, when placement, or replacement, of an indwelling voice prosthesis is performed by a qualified, trained medical professional.

Source page: https://510kreport.com/device/K082206
Methodology: https://510kreport.com/methodology