JAY · Support, Breathing Tube
Anesthesiology · 21 CFR 868.5280 · Class 1
Overview
| Product Code | JAY |
|---|---|
| Device Name | Support, Breathing Tube |
| Regulation | 21 CFR 868.5280 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944988 | CUSTOM MEDICAL SUSPENSION STRAP | Custom Medical Specialties, Inc. | Jan 27, 1995 | SESE |
| K873491 | BLOCK, BITE, INTUBATION | B&B Medical Technologies, Inc. | Oct 20, 1987 | SESE |
| K860583 | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | Dale Medical Products, Inc. | Feb 21, 1986 | SESE |
| K850924 | JEE FRAME (VENTILATOR CIRCUIT SUPPORT) | Vulcan Laboratories, Inc. | Jul 19, 1985 | SESE |
| K850309 | COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK | Ackrad Laboratories | Feb 14, 1985 | SESE |
| K840844 | ENDO-SECURE | Exidyne, Inc. | Mar 16, 1984 | SESE |
| K834265 | TRACH MATE | Tempe Biomedical, Inc. | Jan 4, 1984 | SESE |
| K834089 | COMFIT | Ackrad Laboratories | Dec 29, 1983 | SESE |
| K833374 | BITE-BLOCK | Sontek Industries, Inc. | Nov 3, 1983 | SESE |
| K833361 | TUBE-TITLE | Sontek Industries, Inc. | Nov 3, 1983 | SESE |
| K833332 | SCHULTZ ENDHOLD | Polyclinic Medical Center | Oct 31, 1983 | SESE |
| K832946 | DALE ENDOTRACHEAL TUBE HOLDER | Dale Medical Products, Inc. | Oct 14, 1983 | SESE |
| K802675 | ENDOTRACHEAL TUBE HOLDER | Respiratory Support Products, Inc. | Nov 19, 1980 | SESE |
| K792148 | ADJUSTABLE TUBE TREE FOR ANESTH. HOSES | Medical Innovations Corp. | Nov 15, 1979 | SESE |
| K791781 | TUBE-STRAP | Olympic Medical Corp. | Sep 19, 1979 | SESE |
| K790410 | ADULT ZEE-FRAME | Equilibrated Bio Systems, Inc. | Mar 22, 1979 | SESE |
| K781509 | ZEE-FRAME | Equilibrated Bio Systems, Inc. | Sep 26, 1978 | SESE |
| K770631 | FLEX ARM BE 122, CLAMP 122-27 | Instrumentation Industries, Inc. | May 23, 1977 | SESE |
| K770628 | CLAMP BE-152 | Instrumentation Industries, Inc. | May 23, 1977 | SESE |
Top Applicants
- Ackrad Laboratories — 2 clearances
- Dale Medical Products, Inc. — 2 clearances
- Equilibrated Bio Systems, Inc. — 2 clearances
- Instrumentation Industries, Inc. — 2 clearances
- Sontek Industries, Inc. — 2 clearances
