# K932163: Blom-Singer Voice Prosthesis Flushing Pipet

- Pathway: 510(k) (Traditional)
- Applicant: Helix Medical, Inc.
- Decided: Dec 15, 1993 after 225 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991587: Blom-Singer Indwelling 2000 Voice Prosthesis (1999), 1 descendant of its own
- K082206: Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 Series (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K932163
Methodology: https://510kreport.com/methodology