Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5810](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5810) → BZA — Connector, Airway (Extension) # BZA · Connector, Airway (Extension) _Anesthesiology · 21 CFR 868.5810 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA ## Overview - **Product Code:** BZA - **Device Name:** Connector, Airway (Extension) - **Regulation:** [21 CFR 868.5810](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5810) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask. ## 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 94) Showing 20 most recent of 94 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K083702](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K083702.md) | TRACH-ASSIST | Mergenet Medical | Mar 5, 2009 | SESE | | [K954383](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K954383.md) | SURELOC CIRCUIT CONNECTOR | Polamedco, Inc. | Dec 22, 1995 | SESE | | [K954197](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K954197.md) | DISPOSABLE FLEX TUBE | Engstrom Medical | Oct 26, 1995 | SESE | | [K953786](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K953786.md) | UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS | Unicor, Inc. | Sep 19, 1995 | SESE | | [K952824](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K952824.md) | NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR | Intertex Medical, Inc. | Jul 20, 1995 | SESE | | [K951345](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K951345.md) | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING | Catheter Research, Inc. | Apr 14, 1995 | SESE | | [K944532](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K944532.md) | PRIMA, INC. VENTILATOR HOSES | Prima, Inc. | Dec 2, 1994 | SESE | | [K944535](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K944535.md) | PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS | Prima, Inc. | Nov 29, 1994 | SESE | | [K944534](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K944534.md) | PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS | Prima, Inc. | Nov 29, 1994 | SESE | | [K942392](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K942392.md) | AIRWAY CONNECTOR WITH FLEX TUBE | Mallinckrodt Medical | Aug 22, 1994 | SESE | | [K941026](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K941026.md) | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR | Thayer Medical Corp. | Aug 18, 1994 | SESE | | [K940793](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K940793.md) | DOUBLE TRACH SWIVEL CONNECTOR | Seven Harvest Intl. Import & Export | Jul 1, 1994 | SESE | | [K940544](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K940544.md) | DOUBLE TRACH SEIVEL CONNECTOR | Fvtnks | Apr 19, 1994 | SESE | | [K935821](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K935821.md) | DOUBLE TRACH SWIVEL CONNECTOR | Nutec, Inc. | Jan 14, 1994 | SESE | | [K931800](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K931800.md) | MAG CONNECTORS AND AIRWAY EXTENSIONS | Mag, Inc. | May 19, 1993 | SESE | | [K931345](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K931345.md) | CONNECTORS AND AIRWAY EXTENSIONS | Precision Med Products, Ltd. | Apr 23, 1993 | SESE | | [K931216](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K931216.md) | CONNECTORS AND AIRWAY EXTENSIONS | Teknor Medical Products, Inc. | Apr 23, 1993 | SESE | | [K931038](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K931038.md) | CONNECTORS AND AIRWAY EXTENSIONS | Med-Plastics Intl., Inc. | Apr 8, 1993 | SESE | | [K931036](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K931036.md) | CONNECTORS AND AIRWAY EXTENSIONS | Life Shield Healthcare Products, Inc. | Apr 8, 1993 | SESE | | [K925263](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA/K925263.md) | MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT | Merit Medical Systems, Inc. | Feb 2, 1993 | SESE | ## Top Applicants - Airlife, Inc. — 11 clearances - Dhd Medical Products Div. Diemolding Corp. — 8 clearances - Intersurgical, Inc. — 4 clearances - Dhd Diemolding Healthcare Div. — 3 clearances - Intertech/Ohio — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZA) **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