Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5975](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5975) → BZO — Set, Tubing And Support, Ventilator (W Harness) # BZO · Set, Tubing And Support, Ventilator (W Harness) _Anesthesiology · 21 CFR 868.5975 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO ## Overview - **Product Code:** BZO - **Device Name:** Set, Tubing And Support, Ventilator (W Harness) - **Regulation:** [21 CFR 868.5975](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5975) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient. ## 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 88) Showing 20 most recent of 88 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K953784](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K953784.md) | UNICOR, INC. CORRUGATED TUBING | Unicor, Inc. | Sep 19, 1995 | SESE | | [K953785](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K953785.md) | UNICOR, INC. VENTILATOR HOSES | Unicor, Inc. | Sep 18, 1995 | SESE | | [K952022](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K952022.md) | PRIMA VOLUMN VENTILATORSS | Prima, Inc. | May 22, 1995 | SESE | | [K952012](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K952012.md) | PRIMA CUSTOM ANESTESIA CIRCUIT | Prima, Inc. | May 22, 1995 | SESE | | [K952011](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K952011.md) | PRIMA BREATHING BAGS | Prima, Inc. | May 22, 1995 | SESE | | [K952010](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K952010.md) | PRIMA VENTILATOR HOSES | Prima, Inc. | May 22, 1995 | SESE | | [K945740](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K945740.md) | INFANT FLOW SYSTEM | Hamilton Medical, Inc. | Mar 23, 1995 | SESE | | [K944531](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K944531.md) | PRIMA, INC. CORRUGATED TUBING | Prima, Inc. | Dec 2, 1994 | SESE | | [K942572](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K942572.md) | VOLUME VENTILATOR | Med-Plastics Intl., Inc. | Jun 10, 1994 | SESE | | [K942569](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K942569.md) | VENTILATOR HOSE | Med-Plastics Intl., Inc. | Jun 10, 1994 | SESE | | [K935582](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K935582.md) | TUBE, INHALER OXYGEN | Puritas Health Care, Inc. | Jan 14, 1994 | SESE | | [K934753](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K934753.md) | STAR BREATHING CIRCUITS | Infrasonics Corp. | Oct 27, 1993 | SESE | | [K932706](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K932706.md) | PRECISION MED PRODUCTS LTD. VENTILATOR HOSE | Precision Med Products, Ltd. | Jul 23, 1993 | SESE | | [K932712](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K932712.md) | PRECISION MED PRODUCTS LTD VOLUME VENTILATORS | Precision Med Products, Ltd. | Jul 22, 1993 | SESE | | [K932560](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K932560.md) | VOLUME VENTILATORS | Life Shield Healthcare Products, Inc. | Jul 22, 1993 | SESE | | [K932563](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K932563.md) | VENTILATOR HOSES | Life Shield Healthcare Products, Inc. | Jul 16, 1993 | SESE | | [K932119](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K932119.md) | CLEVELAND TUBING, INC. VENTILATOR HOSES | Cleveland Tubing, Inc. | Jun 23, 1993 | SESE | | [K922479](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K922479.md) | DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED | Intertech Resources, Inc. | Oct 30, 1992 | SESE | | [K921510](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K921510.md) | GAS SAMPLING KIT MODIFICATION | Respiratory Support Products, Inc. | Jun 11, 1992 | SESE | | [K911328](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K911328.md) | UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION | Intertech Resources, Inc. | Aug 15, 1991 | SESE | ## Top Applicants - Airlife, Inc. — 5 clearances - Prima, Inc. — 5 clearances - Nova-Ventrx — 4 clearances - Cygnus Research Corp. — 3 clearances - Dryden Corp. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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