Improved Mouthpiece
FDA 510(k) K840459 · Kinetix
510(k) numberK840459
Submission
- Device name
- Improved Mouthpiece
- Applicant
- Kinetix
Mchenry, IL, US - Received
- February 2, 1984
- Decision date
- February 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYP – Mouthpiece, Breathing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5620
- Specialty
- Anesthesiology
Other 510(k)s with product code BYP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955657 | North State Plastics Respiratory MouthpieceBYP · Traditional | North State Plastics, Inc. | 03/12/1996SE |
| K944512 | Truzone PFM Disposable MouthpieceBYP · Traditional | Monaghan Medical Corp. | 11/02/1994SE |
| K893791 | Breathing MouthpieceBYP · Traditional | Diemolding Corp. | 06/23/1989SE |
| K872037 | AerochamberBYP · Traditional | Monaghan Medical Corp. | 07/24/1987SE |
| K865093 | Safe-T-Shield MouthpieceBYP · Traditional | Medi Nuclear Corp., Inc. | 01/15/1987SE |
| K863049 | Inhalation AidBYP · Traditional | Boehringer Ingelheim Pharmaceuticals, Inc. | 10/15/1986SE |
| K862788 | MP-4400 Mouthpiece-Flange SealBYP · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K853575 | Medipart Mouthpiece MP-1010BYP · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
| K853574 | Medipart Dispos. Mouthpiece W/22MM O.D. MP-4411BYP · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
| K853572 | Medipart Dispos. Mouthpiece W/2MM I.D. MP-4410BYP · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
More from Medipart Jerry Alexander
Questions and answers
When was Improved Mouthpiece cleared by the FDA?
Improved Mouthpiece (K840459) received a 510(k) decision of Substantially Equivalent on February 17, 1984, 15 days after the submission was received.
What is the product code of K840459?
The FDA product code is BYP – Mouthpiece, Breathing, a Class I (low risk) device regulated under 21 CFR 868.5620.