# K130558: Somnodent Herbst; Classic, Flex

- Pathway: 510(k) (Special)
- Applicant: Somnomed, Inc.
- Decided: May 17, 2013 after 74 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: 6 generations back to K882303 (1989). 7 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 24 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.
- K073004: Somnomed  Bflex, Somnomed, Inc. (2008) Summary page 1.
- K121340: Somnodent G2, Somnomed, Inc. (2012) Summary page 1.

## Most influential descendants
- 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
- K161624: MicrO2 OSA Device with Micro-Recorder (2016), 5 descendants of its own
- K202529: ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring (2020), 2 descendants of its own
- K170692: Respire Pink Series with DentiTrac (2017), 2 descendants of its own

## Indications for use
The SomnoDent Herbst is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Source page: https://510kreport.com/device/K130558
Methodology: https://510kreport.com/methodology