Disposable Thermoplastic Rubber Mouth
FDA 510(k) K821128 · Airlife, Inc.
510(k) numberK821128
Submission
- Device name
- Disposable Thermoplastic Rubber Mouth
- Applicant
- Airlife, Inc.
Mchenry, IL, US - Received
- April 20, 1982
- Decision date
- May 13, 1982
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K834573 | Aqua TrapBYH · Traditional | 03/05/1984SE |
| K834570 | Volume Ventilator Circuit W/Water TrapBZO · Traditional | 03/05/1984SE |
| K834077 | Single Use Nebulizer-Adjust-Air EntrainCAF · Traditional | 12/12/1983SE |
| K833196 | Volume Ventilator Circuit-NebulizerCAI · Traditional | 11/03/1983SE |
| K833197 | Trach Swive/ConnectorBTR · Traditional | 10/28/1983SE |
| K832725 | Dual Dial Venturi Style MaskBYF · Traditional | 09/20/1983SE |
| K831246 | Whistler In-Line Pressure Release ValveCBP · Traditional | 07/26/1983SE |
| K830895 | Single Use Nebulizer, Adjust. Air-CAF · Traditional | 04/28/1983SE |
| K830896 | Humidifier, with or Without AdapterKFZ · Traditional | 04/18/1983SE |
| K821129 | Airlife Nebulizer HeaterCAF · Traditional | 05/18/1982SE |
Questions and answers
When was Disposable Thermoplastic Rubber Mouth cleared by the FDA?
Disposable Thermoplastic Rubber Mouth (K821128) received a 510(k) decision of Substantially Equivalent on May 13, 1982, 23 days after the submission was received.
What is the product code of K821128?
The FDA product code is BYP – Mouthpiece, Breathing, a Class I (low risk) device regulated under 21 CFR 868.5620.