One-Way Air Valve
FDA 510(k) K840253 · Delta Medical Industries
510(k) numberK840253
Submission
- Device name
- One-Way Air Valve
- Applicant
- Delta Medical Industries
Mchenry, IL, US - Received
- January 23, 1984
- Decision date
- April 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYZ – Trap, Sterile Specimen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code BYZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925412 | Electromedics Tissue Trap/ #TT280BYZ · Traditional | Electromedics, Inc. | 02/05/1993SE |
| K913643 | Mucous Specimen TrapBYZ · Traditional | Medical Device Inspection Co., Inc. | 10/10/1991SE |
| K902883 | Tissue/Polyp Trap SystemBYZ · Traditional | Triton Technology, Inc. | 09/12/1990SE |
| K841409 | Bush Neck W/PlugBYZ · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
| K834467 | Specimen TrapBYZ · Traditional | Microvasive | 02/17/1984SE |
| K822557 | Specimen AdaptorBYZ · Traditional | Bemis Health Care | 10/18/1982SE |
| K822556 | Critical Measurement UnitBYZ · Traditional | Bemis Health Care | 10/18/1982SE |
| K791847 | Aspri-LukeBYZ · Traditional | Medical Marketing Group | 10/02/1979SE |
More from Medical Marketing Group
| 510(k) | Device | Decision |
|---|---|---|
| K833884 | Isotec Dispos. Pressure Transducer · Traditional | 04/17/1984SE |
| K832470 | Infusion PumpFRN · Traditional | 02/28/1984SE |
| K830389 | Accu-Rynge Pump SP-250FRN · Traditional | 09/12/1983SE |
| K831750 | PM-3DXS · Traditional | 07/26/1983SE |
| K822761 | Delivery Tube Set #2226FRN · Traditional | 09/30/1982SE |
| K820912 | PMS-2 Pressure Monitor SeparatorDXS · Traditional | 05/18/1982SE |
| K820482 | Accu-Rynge Insulin Pump #SP-250FRN · Traditional | 03/26/1982SE |
| K810068 | Pediatric Arterial Blood FilterDTM · Traditional | 01/22/1981SE |
| K802755 | Arterial Blood Filter BF-37DTM · Traditional | 01/07/1981SE |
| K803102 | Arterial Bubble Trap K-20KRL · Traditional | 12/22/1980SE |
Questions and answers
When was One-Way Air Valve cleared by the FDA?
One-Way Air Valve (K840253) received a 510(k) decision of Substantially Equivalent on April 5, 1984, 73 days after the submission was received.
What is the product code of K840253?
The FDA product code is BYZ – Trap, Sterile Specimen, a Class II (moderate risk) device regulated under 21 CFR 880.6740.