Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5375](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5375) → BYD — Condenser, Heat And Moisture (Artificial Nose) # BYD · Condenser, Heat And Moisture (Artificial Nose) _Anesthesiology · 21 CFR 868.5375 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD ## Overview - **Product Code:** BYD - **Device Name:** Condenser, Heat And Moisture (Artificial Nose) - **Regulation:** [21 CFR 868.5375](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5375) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a 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 73) Showing 20 most recent of 73 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K955008](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K955008.md) | HEAT & MOISTURE EXCHANGER | Intertech Resources, Inc. | Jan 30, 1996 | SESE | | [K954194](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K954194.md) | DISPOSABLE HME/FILTER | Engstrom Medical | Oct 20, 1995 | SESE | | [K953580](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K953580.md) | HEAT MOISTURE EXCHANGER | Intertech Resources, Inc. | Sep 15, 1995 | SESE | | [K953507](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K953507.md) | TYPE 1 & 2 (HUMIDAIR I & II) | Icor AB | Sep 7, 1995 | SESE | | [K953620](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K953620.md) | WARM N WET HMEF W/LUER ADAPTER | Hospitak, Inc. | Aug 25, 1995 | SESE | | [K953619](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K953619.md) | WARM N WET HME W/LUER ADAPTER | Hospitak, Inc. | Aug 25, 1995 | SESE | | [K953544](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K953544.md) | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | Gibeck, Inc. | Aug 25, 1995 | SESE | | [K953540](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K953540.md) | EEE | Edentec Corp. | Aug 25, 1995 | SESE | | [K953491](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K953491.md) | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | Gibeck, Inc. | Aug 25, 1995 | SESE | | [K952845](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K952845.md) | HUMID-VENT TRACH-VENT | Gibeck, Inc. | Jul 25, 1995 | SESE | | [K952844](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K952844.md) | HUMID-VENT 2 | Gibeck, Inc. | Jul 20, 1995 | SESE | | [K952750](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K952750.md) | HUMID-VENT 1 | Gibeck, Inc. | Jul 20, 1995 | SESE | | [K952823](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K952823.md) | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE | Icor AB | Jul 13, 1995 | SESE | | [K952084](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K952084.md) | HUMID-VENT FILTER PEDI | Gibeck, Inc. | Jun 12, 1995 | SESE | | [K952036](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K952036.md) | FLEXLIFE | Mallinckrodt Medical | Jun 8, 1995 | SESE | | [K946209](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K946209.md) | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | Med-Plastics Intl., Inc. | Jun 8, 1995 | SESE | | [K951856](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K951856.md) | HUMID-VENT MICRO | Gibeck, Inc. | Jun 7, 1995 | SESE | | [K950447](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K950447.md) | FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT | Vital Signs, Inc. | Feb 21, 1995 | SESE | | [K945359](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K945359.md) | AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H | Artema Medical AB | Feb 21, 1995 | SESE | | [K945657](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K945657.md) | DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER | Tec II Medical, Inc. | Dec 7, 1994 | SESE | ## Top Applicants - Icor AB — 9 clearances - Gibeck, Inc. — 7 clearances - Gibeck Respiration — 6 clearances - Artema Medical AB — 5 clearances - Mallinckrodt Medical — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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