Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5280](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5280) → JAY — Support, Breathing Tube # JAY · Support, Breathing Tube _Anesthesiology · 21 CFR 868.5280 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY ## Overview - **Product Code:** JAY - **Device Name:** Support, Breathing Tube - **Regulation:** [21 CFR 868.5280](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5280) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K944988.md) | CUSTOM MEDICAL SUSPENSION STRAP | Custom Medical Specialties, Inc. | Jan 27, 1995 | SESE | | [K873491](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K873491.md) | BLOCK, BITE, INTUBATION | B&B Medical Technologies, Inc. | Oct 20, 1987 | SESE | | [K860583](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K860583.md) | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | Dale Medical Products, Inc. | Feb 21, 1986 | SESE | | [K850924](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K850924.md) | JEE FRAME (VENTILATOR CIRCUIT SUPPORT) | Vulcan Laboratories, Inc. | Jul 19, 1985 | SESE | | [K850309](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K850309.md) | COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK | Ackrad Laboratories | Feb 14, 1985 | SESE | | [K840844](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K840844.md) | ENDO-SECURE | Exidyne, Inc. | Mar 16, 1984 | SESE | | [K834265](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K834265.md) | TRACH MATE | Tempe Biomedical, Inc. | Jan 4, 1984 | SESE | | [K834089](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K834089.md) | COMFIT | Ackrad Laboratories | Dec 29, 1983 | SESE | | [K833374](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K833374.md) | BITE-BLOCK | Sontek Industries, Inc. | Nov 3, 1983 | SESE | | [K833361](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K833361.md) | TUBE-TITLE | Sontek Industries, Inc. | Nov 3, 1983 | SESE | | [K833332](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K833332.md) | SCHULTZ ENDHOLD | Polyclinic Medical Center | Oct 31, 1983 | SESE | | [K832946](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K832946.md) | DALE ENDOTRACHEAL TUBE HOLDER | Dale Medical Products, Inc. | Oct 14, 1983 | SESE | | [K802675](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K802675.md) | ENDOTRACHEAL TUBE HOLDER | Respiratory Support Products, Inc. | Nov 19, 1980 | SESE | | [K792148](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K792148.md) | ADJUSTABLE TUBE TREE FOR ANESTH. HOSES | Medical Innovations Corp. | Nov 15, 1979 | SESE | | [K791781](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K791781.md) | TUBE-STRAP | Olympic Medical Corp. | Sep 19, 1979 | SESE | | [K790410](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K790410.md) | ADULT ZEE-FRAME | Equilibrated Bio Systems, Inc. | Mar 22, 1979 | SESE | | [K781509](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K781509.md) | ZEE-FRAME | Equilibrated Bio Systems, Inc. | Sep 26, 1978 | SESE | | [K770631](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K770631.md) | FLEX ARM BE 122, CLAMP 122-27 | Instrumentation Industries, Inc. | May 23, 1977 | SESE | | [K770628](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY/K770628.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JAY) **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