Bag, Reservoir
The Bag, Reservoir is a compliant breathing bag used in anesthesia circuits to store respiratory gases, assist in manual ventilation, and allow the anesthesiologist to monitor and control the patient's breathing. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is BTC, regulated under 21 CFR 868.5320 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BTC
- Device Class
- FDA class 1
- Regulation Number
- 868.5320
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K181424 | PeDIA | Sep 25, 2018 | Substantially Equivalent | Pedia, LLC |
| K940220 | REBREATHER BAGS | May 27, 1994 | Substantially Equivalent | Zefon Medical Products |
| K932584 | BREATHING BAGS | Jul 16, 1993 | Substantially Equivalent | Merit Medical Systems, Inc. |
| K932581 | BREATHING BAGS | Jul 16, 1993 | Substantially Equivalent | Med-Plastics Intl., Inc. |
| K932496 | PRECISION MED PRODUCTS, LTD. BREATHING BAGS | Jul 16, 1993 | Substantially Equivalent | Precision Med Products, Ltd. |
| K932191 | BREATHING BAGS | Jul 02, 1993 | Substantially Equivalent | Life Shield Healthcare Products, Inc. |
| K894906 | ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER | Sep 18, 1989 | Substantially Equivalent | Med-Tek Corp. |
| K880680 | KING SYSTEMS, BREATHING BAG | Mar 03, 1988 | Substantially Equivalent | King Systems Corp. |
| K864822 | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS | Jan 15, 1987 | Substantially Equivalent | Surgidyne, Inc. |
| K841412 | ROLLED NECK W/TAP | Apr 18, 1984 | Substantially Equivalent | Warne Surgical Products, Ltd. |
| K841411 | ROLLED NECK W/PLUG | Apr 18, 1984 | Substantially Equivalent | Warne Surgical Products, Ltd. |
| K830399 | COUPLING/VALVE | Mar 10, 1983 | Substantially Equivalent | Khi, Inc. |
| K830056 | ARTEC TWIST VALVE | Mar 09, 1983 | Substantially Equivalent | Artec Environmental Monitoring Division |
| K822216 | VOLUMETRIC CONTROLLER | Aug 16, 1982 | Substantially Equivalent | Quest Medical, Inc. |
| K822116 | ANESTHESIA BREATHING BAG, VARIOUS SIZES | Aug 16, 1982 | Substantially Equivalent | Life Design Systems, Inc. |
| K821309 | ESPREE', BREATHING BAG | May 21, 1982 | Substantially Equivalent | Esp Plastics, Inc. |
| K800155 | DISPOSAL LITER BREATHING BAG | Feb 21, 1980 | Substantially Equivalent | Dryden Corp. |
| K791910 | THREE LITER BAG #M-512 | Oct 09, 1979 | Substantially Equivalent | Mem Medical, Inc. |
| K791463 | PARA-VENT | Sep 17, 1979 | Substantially Equivalent | Cameron Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 94 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 94 registration numbers. Click on an entry to view related FDA registrations.