Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart G — Miscellaneous](/submissions/AN/subpart-g%E2%80%94miscellaneous) → [21 CFR 868.6400](/submissions/AN/subpart-g%E2%80%94miscellaneous/868.6400) → BXK — Gas, Calibration (Specified Concentration) # BXK · Gas, Calibration (Specified Concentration) _Anesthesiology · 21 CFR 868.6400 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK ## Overview - **Product Code:** BXK - **Device Name:** Gas, Calibration (Specified Concentration) - **Regulation:** [21 CFR 868.6400](/submissions/AN/subpart-g%E2%80%94miscellaneous/868.6400) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices. ## 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 32) Showing 20 most recent of 32 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K954804](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K954804.md) | LUNG DIFFUSION MIXTURES | Mittler Supply, Inc. | Jan 25, 1996 | SESE | | [K954803](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K954803.md) | BLOOD GAS MIXTURES | Mittler Supply, Inc. | Jan 25, 1996 | SESE | | [K954542](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K954542.md) | LUNG DIFFUSION MIXTURE | Liquid Technology Corp. | Dec 22, 1995 | SESE | | [K952838](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K952838.md) | MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES | Standard Welders Supply Co. | Sep 19, 1995 | SESE | | [K953934](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K953934.md) | MED-TECH LUNG DIFFUSION MIXTURE | Medical Technical Gases Inc.. | Sep 18, 1995 | SESE | | [K953208](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K953208.md) | MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES | Standard Welders Supply Co. | Jul 20, 1995 | SESE | | [K944998](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K944998.md) | CALIBRATION GAS | Sunox, Inc. | Feb 3, 1995 | SESE | | [K944812](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K944812.md) | CLINICAL BLOOD GAS MIXTURE | Laboratory & Specialty Gases, Inc. | Feb 1, 1995 | SESE | | [K942866](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K942866.md) | CLINICAL BLOOD GAS MIXTURE | Nordan Smith Welding Supplies | Sep 1, 1994 | SESE | | [K932874](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K932874.md) | BLOOD GAS MIXTURE | Tri-Gas, Inc. | Jan 27, 1994 | SESE | | [K935311](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K935311.md) | CLINICAL BLOOD GAS | Acetylene Gas Co. | Dec 22, 1993 | SESE | | [K932520](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K932520.md) | CALIBRATION GAS | Cryodyne Technologies, Inc. | Aug 19, 1993 | SESE | | [K924796](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K924796.md) | LUNG DIFFUSION GAS MIXTURE | Gulf States Airgas | Dec 17, 1992 | SESE | | [K924795](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K924795.md) | BLOOD GAS MIXTURE | Gulf States Airgas | Dec 17, 1992 | SESE | | [K911264](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K911264.md) | CALIBRATION KIT | S & W Medico Teknik | Aug 2, 1991 | SESE | | [K911471](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K911471.md) | LUNG DIFFUSION GAS MIXTURES | Norco, Inc. | Jun 18, 1991 | SESE | | [K902754](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K902754.md) | ANESTHETIC GAS CALIBRATION MIXTURE | Liquid Air Corp. | Dec 19, 1990 | SESE | | [K882210](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K882210.md) | MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES | Linde Div. Union Carbide Corp. | Jun 21, 1988 | SESE | | [K873586](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K873586.md) | LUNG DIFFUSION GAS | National Welders | Feb 12, 1988 | SESE | | [K874297](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK/K874297.md) | CALIBRATION GAS FOR CARBON DIOXIDE MONITOR | Liquid Air Corp. | Dec 21, 1987 | SESE | ## Top Applicants - Liquid Carbonic Corp. — 5 clearances - Matheson Gas Products, Inc. — 4 clearances - Gulf States Airgas — 2 clearances - Liquid Air Corp. — 2 clearances - Mittler Supply, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BXK) **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. 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