# K991587: Blom-Singer Indwelling 2000 Voice Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Helix Medical, Inc.
- Decided: Jun 25, 1999 after 49 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: 1 generation back to K930105 (1993). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.
- K971244: Provox 2 Voice Prosthesis System, Atos Medical AB (1997) Summary page 1.
- K930105: Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S., Helix Medical, Inc. (1993) Summary page 1.
- K932163: Blom-Singer Voice Prosthesis Flushing Pipet, Helix Medical, Inc. (1993) Summary page 1.
- K945288: Inhealth Blom-Singer Indwelling Plug Insert Accessory Device, Helix Medical, Inc. (1994) Summary page 1.
- (no number) Blom-Singer Indwelling Low Pressure Voice Prosthesis: named in the summary without a submission number

## Most influential descendants
- K082206: Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 Series (2008), 0 descendants of its own

## Indications for use
The Blom-Singer Indwelling 2000 Voice Prosthesis is for voice rehabilitation following total laryngectomy where placement/replacement of the voice prosthesis is done by a clinician. The Blom-Singer Indwelling 2000 Voice Prosthesis may be placed at the time of surgery or may be placed at a later date secondary to the laryngectomy.

Source page: https://510kreport.com/device/K991587
Methodology: https://510kreport.com/methodology