Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5240](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5240) → CAI — Circuit, Breathing (W Connector, Adaptor, Y Piece) # CAI · Circuit, Breathing (W Connector, Adaptor, Y Piece) _Anesthesiology · 21 CFR 868.5240 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI ## Overview - **Product Code:** CAI - **Device Name:** Circuit, Breathing (W Connector, Adaptor, Y Piece) - **Regulation:** [21 CFR 868.5240](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5240) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece. ## 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 184) Showing 20 most recent of 184 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K954480](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K954480.md) | CONDENSATE COLLECTION KIT | Nova-Ventrx | Dec 29, 1995 | SESE | | [K953788](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K953788.md) | UNICOR, INC. GAS SAMPLING LINES & CONNECTORS | Unicor, Inc. | Sep 19, 1995 | SESE | | [K953787](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K953787.md) | UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT | Unicor, Inc. | Sep 19, 1995 | SESE | | [K952020](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K952020.md) | PRIMA PEDIATRIC ANESTHESIA CIRCUITS | Prima, Inc. | May 22, 1995 | SESE | | [K952019](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K952019.md) | PRIMA ADULT GAS SAMPLING CIRCUITS | Prima, Inc. | May 22, 1995 | SESE | | [K952018](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K952018.md) | PRIMA COAXIAL CIRCUITS | Prima, Inc. | May 22, 1995 | SESE | | [K952017](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K952017.md) | PRIMA MAPLESON D CIRCUIT | Prima, Inc. | May 22, 1995 | SESE | | [K952016](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K952016.md) | PRIMA PEDIATRIC GAS SAMPLING CIRCUITS | Prima, Inc. | May 22, 1995 | SESE | | [K952014](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K952014.md) | PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | Prima, Inc. | May 22, 1995 | SESE | | [K952009](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K952009.md) | PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS | Prima, Inc. | May 19, 1995 | SESE | | [K945565](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K945565.md) | SPIRO-FLEX | Inhalation Plastics | Jan 13, 1995 | SESE | | [K932288](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K932288.md) | NEONATAL BREATHING CIRCUIT MODIFICATION | Simplex Medical Systems, Inc. | Dec 30, 1994 | SESE | | [K945984](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K945984.md) | MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS | Meridian Medical Systems, Inc. | Dec 27, 1994 | SESE | | [K944533](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K944533.md) | PRIMA, INC. ADULT ANESTHESIA CIRCUIT | Prima, Inc. | Nov 29, 1994 | SESE | | [K945314](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K945314.md) | CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING | Cleveland Tubing, Inc. | Nov 18, 1994 | SESE | | [K944429](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K944429.md) | PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING | Precision Thermoplastic Components, Inc. | Nov 18, 1994 | SESE | | [K940890](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K940890.md) | CORRUGATED TUBING | Cleveland Tubing, Inc. | Nov 10, 1994 | SESE | | [K940889](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K940889.md) | CONNECTORS AND AIRWAY EXTENSIONS | Cleveland Tubing, Inc. | Nov 10, 1994 | SESE | | [K944295](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K944295.md) | KARL STORZ LARYNGOSCOPE ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Oct 4, 1994 | SESE | | [K942136](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI/K942136.md) | M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS | Mag, Inc. | Jun 22, 1994 | SESE | ## Top Applicants - Mag, Inc. — 15 clearances - Sigma Medical, Inc. — 13 clearances - Life Shield Healthcare Products, Inc. — 10 clearances - Precision Med Products, Ltd. — 10 clearances - Med-Plastics Intl., Inc. — 9 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAI) **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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