Tap Anti-Snoring Device
FDA 510(k) K962516 · Nellcor Puritan Bennett, Inc.
510(k) numberK962516
Submission
- Device name
- Tap Anti-Snoring Device
- Applicant
- Nellcor Puritan Bennett, Inc.
Eden Prairie, MN, US - Received
- June 27, 1996
- Decision date
- September 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)LRK · Special | Ram.Shaw Pte., Ltd. | 08/27/2026SE |
| K261912 | SnØreNegatØrLRK · Traditional | DnB Innovations, LLC | 07/31/2026SE |
| K261366 | VirtusLRK · Special | Somnomed, Inc. | 06/12/2026SE |
| K261251 | Snorbliss® Anti-Snoring DeviceLRK · Traditional | Endeavor Commerce, LLC | 06/11/2026SE |
| K261134 | Dormiva Anti-Snoring Mouth GuardLRK · Special | Koncept Innovators, Inc. | 05/14/2026SE |
| K252942 | ShaeferHLRK · Traditional | Shaeferh, LLC | 04/10/2026SE |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)LRK · Traditional | Ram.Shaw Pte. , Ltd. | 03/03/2026SE |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)LRK · Traditional | Myofunctional Research Co. | 03/02/2026SE |
| K252976 | Park Dental Nylon MADLRK · Traditional | Park Dental Research Corp. | 12/18/2025SE |
| K253868 | QuietLab ProLRK · Traditional | QuietLab, LLC | 12/05/2025SE |
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| K052186 | Nellcor Oximax Pulse Oximetry Sensons (Max-A, Max-Al, Max-N, Max-I, Max-PDQA · Special | 11/10/2005SE |
| K051352 | Oximax NPB-40 Handheld Pulse OximeterDQA · Traditional | 08/11/2005SE |
| K050072 | Goodknight 425STBZD · Special | 06/13/2005SE |
| K033973 | Oxisensor II Recycled Sensor and Oximax Recycled SensorNLF · Traditional | 12/13/2004SE |
| K030787 | Shiley Flextra Tracheostomy TubeJOH · Traditional | 11/14/2003SE |
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Questions and answers
When was Tap Anti-Snoring Device cleared by the FDA?
Tap Anti-Snoring Device (K962516) received a 510(k) decision of Substantially Equivalent on September 10, 1996, 75 days after the submission was received.
What is the product code of K962516?
The FDA product code is LRK – Device, Anti-Snoring, a Class II (moderate risk) device regulated under 21 CFR 872.5570.