# K030440: Oasys-Oral Airway System

- Pathway: 510(k) (Abbreviated)
- Applicant: Mark Abramson, D.D.S., Inc.
- Decided: Aug 26, 2003 after 196 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). 8 ancestors in all.
65 later devices descend from it; 6 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972061: TOA, W. Keith Thornton, D.D.S. (1997) Summary page 1.
- K963063: Snore Tec, Marketing Technologies, Inc. (1997) Summary page 1.
- K962516: Tap Anti-Snoring Device, Nellcor Puritan Bennett, Inc. (1996) Summary page 1.
- K022891: The Breathe EZ Anti-Snoring Device, D&S Redhage (2003). Cleared while this submission was under review
- K991948: DR. B'S Mouthpiece, Model 32129-10002, Snore - Ezzer (1999) Summary page 2.

## Cited in the summary but kept off the family tree
- K963616: Aloka SSD-1700 Diagnostic Ultrasound System, Aloka Co., Ltd. (1997). Our reading of the summary gave K963616, FDA’s number for Aloka SSD-1700 Diagnostic Ultrasound System (Aloka Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Marketing Technologies, Inc.”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K060388: Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment (2006), 51 descendants of its own
- K061732: TAP-T (2006), 32 descendants of its own
- K103076: Dynaflex (2011), 29 descendants of its own
- K130130: Atg/SM-Osa Appliances (2013), 17 descendants of its own
- K062951: Tap Iii Anti-Snoring Device (2006), 15 descendants of its own

## Indications for use
OASY.S Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.

Source page: https://510kreport.com/device/K030440
Methodology: https://510kreport.com/methodology