Product code JAY
- Device name
- Support, Breathing Tube
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5280
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944988 | CUSTOM MEDICAL SUSPENSION STRAP | Custom Medical Specialties, Inc. | 1995-01-27 |
| K873491 | BLOCK, BITE, INTUBATION | B&B Medical Technologies, Inc. | 1987-10-20 |
| K860583 | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | Dale Medical Products, Inc. | 1986-02-21 |
| K850924 | JEE FRAME (VENTILATOR CIRCUIT SUPPORT) | Vulcan Laboratories, Inc. | 1985-07-19 |
| K850309 | COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK | Ackrad Laboratories | 1985-02-14 |
| K840844 | ENDO-SECURE | Exidyne, Inc. | 1984-03-16 |
| K834265 | TRACH MATE | Tempe Biomedical, Inc. | 1984-01-04 |
| K834089 | COMFIT | Ackrad Laboratories | 1983-12-29 |
| K833361 | TUBE-TITLE | Sontek Industries, Inc. | 1983-11-03 |
| K833374 | BITE-BLOCK | Sontek Industries, Inc. | 1983-11-03 |
| K833332 | SCHULTZ ENDHOLD | Polyclinic Medical Center | 1983-10-31 |
| K832946 | DALE ENDOTRACHEAL TUBE HOLDER | Dale Medical Products, Inc. | 1983-10-14 |
| K802675 | ENDOTRACHEAL TUBE HOLDER | Respiratory Support Products, Inc. | 1980-11-19 |
| K792148 | ADJUSTABLE TUBE TREE FOR ANESTH. HOSES | Medical Innovations Corp. | 1979-11-15 |
| K791781 | TUBE-STRAP | Olympic Medical Corp. | 1979-09-19 |
| K790410 | ADULT ZEE-FRAME | Equilibrated Bio Systems, Inc. | 1979-03-22 |
| K781509 | ZEE-FRAME | Equilibrated Bio Systems, Inc. | 1978-09-26 |
| K770628 | CLAMP BE-152 | Instrumentation Industries, Inc. | 1977-05-23 |
| K770631 | FLEX ARM BE 122, CLAMP 122-27 | Instrumentation Industries, Inc. | 1977-05-23 |
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|---|---|---|---|
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| 00860013561406 | MPV | Movair, Inc. | 2025-03-12 |
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