# K073004: Somnomed  Bflex

- Pathway: 510(k) (Traditional)
- Applicant: Somnomed, Inc.
- Decided: Jan 30, 2008 after 98 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K882303 (1989). 5 ancestors in all.
32 later devices descend from it; 8 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050592: Somnomed Mas Rxa, Somnomed, Ltd. (2005) Summary page 1.

## Most influential descendants
- K121340: Somnodent G2 (2012), 18 descendants of its own
- K130558: Somnodent Herbst; Classic, Flex (2013), 16 descendants of its own
- K140278: Somnodent Fusion, Classic; Somnodent Fusion, Flex (2014), 14 descendants of its own
- K150369: SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder (2015), 12 descendants of its own
- K111207: Respire Blue Series (2011), 11 descendants of its own

## Indications for use
The SomnoMed MAS Flex "S" is intended to reduce or alleviate night time Snoring and mild to moderate Obstructive Sleep Apnea (OSA).

Source page: https://510kreport.com/device/K073004
Methodology: https://510kreport.com/methodology