# K103076: Dynaflex

- Pathway: 510(k) (Traditional)
- Applicant: Dyna Flex
- Decided: Feb 23, 2011 after 128 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: 7 generations back to K882303 (1989). 15 ancestors in all.
29 later devices descend from it; 6 cite it directly.
0 of 45 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 3.
- K083209: Acrylic Herbst Splint Appliance, Specialty Appliance Works, Inc. (2009) Summary page 3.
- K061732: TAP-T, Airway Management, Inc. (2006) Summary page 3.

## Most influential descendants
- K130130: Atg/SM-Osa Appliances (2013), 17 descendants of its own
- K160234: OVENT (2016), 8 descendants of its own
- K161832: O2VENT T (2016), 7 descendants of its own
- K192581: The NightBlocks Appliance (2020), 6 descendants of its own
- K171316: O2Vent W (2017), 6 descendants of its own

## Indications for use
Dynalex® Anti-Snoring & Sleep Apnea Devices are intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The devices are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist, and is removable by the patient.

Source page: https://510kreport.com/device/K103076
Methodology: https://510kreport.com/methodology