CAT · Cannula, Nasal, Oxygen
Anesthesiology · 21 CFR 868.5340 · Class 1
Overview
| Product Code | CAT |
|---|---|
| Device Name | Cannula, Nasal, Oxygen |
| Regulation | 21 CFR 868.5340 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.
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 (20 of 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K011125 | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI | Hudson Respiratory Care, Inc. | Jun 13, 2001 | SESE |
| K935533 | NASAL CANNULA | Puritas Health Care, Inc. | Feb 3, 1994 | SESE |
| K922397 | 4 SURE TM NASAL OXYGEN CANNULA | Boston Pacific Medical, Inc. | Mar 18, 1993 | SESE |
| K921496 | SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED | Alpine Specialties, Inc. | Aug 14, 1992 | SESE |
| K920573 | CANNULA NASAL OXYGEN | B & F Medical Products, Inc. | Aug 11, 1992 | SESE |
| K913421 | NASAL OXYGEN CANNULA, 81585, 81587 & 81589 | Specialty Packaging Producs, Inc. | Oct 18, 1991 | SESE |
| K912197 | SKIN SAVER(TM) TUBING HOLDER, MODEL 467 | Alpine Specialties, Inc. | Aug 20, 1991 | SESE |
| K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | Salter Labs | Jul 24, 1991 | SESE |
| K902420 | CATHETER, NASAL, OXYGEN | Gainor Medical Europe, Ltd. | Apr 17, 1991 | SESE |
| K896036 | THE COMFORTABLE CANNULA | Comfortable Concepts Corp. | Nov 17, 1989 | SESE |
| K892435 | KENDALL CURITY OXYGEN NASAL CANNULA | The Kendal Co. | Jun 12, 1989 | SESE |
| K884149 | COMFORT STRAP | Comfort Strap Co. | Oct 21, 1988 | SESE |
| K863432 | OXYGEN CANNULA EAR WRAP (STYLE B) | Salter Labs | Sep 18, 1986 | SESE |
| K863431 | OXYGEN CANNULA EAR WRAP (STYLE A) | Salter Labs | Sep 18, 1986 | SESE |
| K860535 | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) | Andover Medical, Inc. | Apr 1, 1986 | SESE |
| K860872 | NASAL CANNULA W/2M & 5M TUBING | Dhd Medical Products Div. Diemolding Corp. | Mar 19, 1986 | SESE |
| K860261 | CANNULA BAND | T. G. & E. Medical | Feb 18, 1986 | SESE |
| K852628 | NASAL ONE | Ashai Co. , Ltd. | Sep 18, 1985 | SESE |
| K852625 | OXY-TUBE | Ashai Co. , Ltd. | Sep 18, 1985 | SESE |
| K850066 | OMNIMED NASAL OXYGEN CANNULA | Omni Intl., Inc. | Jan 24, 1985 | SESE |
Top Applicants
- Salter Labs — 3 clearances
- Alpine Specialties, Inc. — 2 clearances
- Ashai Co. , Ltd. — 2 clearances
- Hudson Extrusions, Inc. — 2 clearances
- Airlife, Inc. — 1 clearance
