# K821568: Blow-Singer Tracheostoma Valve

- Pathway: 510(k) (Traditional)
- Applicant: Bivona Medical Technologies
- Decided: Jul 26, 1982 after 60 days
- Product code: EWL (Prosthesis, Laryngeal (Taub))
- Device class: 2
- Regulation: 21 CFR 874.3730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K022125: Provox Freehands Hme, Model 7710 (2002), 2 descendants of its own
- K141380: Provox Freehands Flexivoice (2014), 0 descendants of its own
- K072582: Provox Micron Hme (2008), 0 descendants of its own
- K043138: Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134 (2004), 0 descendants of its own
- K013728: Trach Vox (2002), 0 descendants of its own

## Recalls of this device
- Oct 1, 2013 · Class III · Z-0128-2014: InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product ca

Source page: https://510kreport.com/device/K821568
Methodology: https://510kreport.com/methodology