Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5320](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5320) → BTC — Bag, Reservoir # BTC · Bag, Reservoir _Anesthesiology · 21 CFR 868.5320 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC ## Overview - **Product Code:** BTC - **Device Name:** Bag, Reservoir - **Regulation:** [21 CFR 868.5320](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5320) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation. ## 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 (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K181424](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K181424.md) | PeDIA | Pedia, LLC | Sep 25, 2018 | SESE | | [K940220](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K940220.md) | REBREATHER BAGS | Zefon Medical Products | May 27, 1994 | SESE | | [K932584](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K932584.md) | BREATHING BAGS | Merit Medical Systems, Inc. | Jul 16, 1993 | SESE | | [K932581](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K932581.md) | BREATHING BAGS | Med-Plastics Intl., Inc. | Jul 16, 1993 | SESE | | [K932496](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K932496.md) | PRECISION MED PRODUCTS, LTD. BREATHING BAGS | Precision Med Products, Ltd. | Jul 16, 1993 | SESE | | [K932191](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K932191.md) | BREATHING BAGS | Life Shield Healthcare Products, Inc. | Jul 2, 1993 | SESE | | [K894906](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K894906.md) | ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER | Med-Tek Corp. | Sep 18, 1989 | SESE | | [K880680](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K880680.md) | KING SYSTEMS, BREATHING BAG | King Systems Corp. | Mar 3, 1988 | SESE | | [K864822](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K864822.md) | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS | Surgidyne, Inc. | Jan 15, 1987 | SESE | | [K841412](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K841412.md) | ROLLED NECK W/TAP | Warne Surgical Products, Ltd. | Apr 18, 1984 | SESE | | [K841411](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K841411.md) | ROLLED NECK W/PLUG | Warne Surgical Products, Ltd. | Apr 18, 1984 | SESE | | [K830399](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K830399.md) | COUPLING/VALVE | Khi, Inc. | Mar 10, 1983 | SESE | | [K830056](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K830056.md) | ARTEC TWIST VALVE | Artec Environmental Monitoring Division | Mar 9, 1983 | SESE | | [K822216](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K822216.md) | VOLUMETRIC CONTROLLER | Quest Medical, Inc. | Aug 16, 1982 | SESE | | [K822116](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K822116.md) | ANESTHESIA BREATHING BAG, VARIOUS SIZES | Life Design Systems, Inc. | Aug 16, 1982 | SESE | | [K821309](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K821309.md) | ESPREE', BREATHING BAG | Esp Plastics, Inc. | May 21, 1982 | SESE | | [K800155](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K800155.md) | DISPOSAL LITER BREATHING BAG | Dryden Corp. | Feb 21, 1980 | SESE | | [K791910](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K791910.md) | THREE LITER BAG #M-512 | Mem Medical, Inc. | Oct 9, 1979 | SESE | | [K791463](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K791463.md) | PARA-VENT | Cameron Medical Corp. | Sep 17, 1979 | SESE | ## Top Applicants - Warne Surgical Products, Ltd. — 2 clearances - Artec Environmental Monitoring Division — 1 clearance - Cameron Medical Corp. — 1 clearance - Dryden Corp. — 1 clearance - Esp Plastics, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC) **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