Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5340](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5340) → CAT — Cannula, Nasal, Oxygen # CAT · Cannula, Nasal, Oxygen _Anesthesiology · 21 CFR 868.5340 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT ## Overview - **Product Code:** CAT - **Device Name:** Cannula, Nasal, Oxygen - **Regulation:** [21 CFR 868.5340](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5340) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K011125.md) | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI | Hudson Respiratory Care, Inc. | Jun 13, 2001 | SESE | | [K935533](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K935533.md) | NASAL CANNULA | Puritas Health Care, Inc. | Feb 3, 1994 | SESE | | [K922397](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K922397.md) | 4 SURE TM NASAL OXYGEN CANNULA | Boston Pacific Medical, Inc. | Mar 18, 1993 | SESE | | [K921496](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K921496.md) | SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED | Alpine Specialties, Inc. | Aug 14, 1992 | SESE | | [K920573](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K920573.md) | CANNULA NASAL OXYGEN | B & F Medical Products, Inc. | Aug 11, 1992 | SESE | | [K913421](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K913421.md) | NASAL OXYGEN CANNULA, 81585, 81587 & 81589 | Specialty Packaging Producs, Inc. | Oct 18, 1991 | SESE | | [K912197](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K912197.md) | SKIN SAVER(TM) TUBING HOLDER, MODEL 467 | Alpine Specialties, Inc. | Aug 20, 1991 | SESE | | [K911740](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K911740.md) | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | Salter Labs | Jul 24, 1991 | SESE | | [K902420](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K902420.md) | CATHETER, NASAL, OXYGEN | Gainor Medical Europe, Ltd. | Apr 17, 1991 | SESE | | [K896036](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K896036.md) | THE COMFORTABLE CANNULA | Comfortable Concepts Corp. | Nov 17, 1989 | SESE | | [K892435](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K892435.md) | KENDALL CURITY OXYGEN NASAL CANNULA | The Kendal Co. | Jun 12, 1989 | SESE | | [K884149](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K884149.md) | COMFORT STRAP | Comfort Strap Co. | Oct 21, 1988 | SESE | | [K863432](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K863432.md) | OXYGEN CANNULA EAR WRAP (STYLE B) | Salter Labs | Sep 18, 1986 | SESE | | [K863431](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K863431.md) | OXYGEN CANNULA EAR WRAP (STYLE A) | Salter Labs | Sep 18, 1986 | SESE | | [K860535](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K860535.md) | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) | Andover Medical, Inc. | Apr 1, 1986 | SESE | | [K860872](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K860872.md) | NASAL CANNULA W/2M & 5M TUBING | Dhd Medical Products Div. Diemolding Corp. | Mar 19, 1986 | SESE | | [K860261](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K860261.md) | CANNULA BAND | T. G. & E. Medical | Feb 18, 1986 | SESE | | [K852628](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K852628.md) | NASAL ONE | Ashai Co. , Ltd. | Sep 18, 1985 | SESE | | [K852625](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K852625.md) | OXY-TUBE | Ashai Co. , Ltd. | Sep 18, 1985 | SESE | | [K850066](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT/K850066.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com