BTC · Bag, Reservoir
Anesthesiology · 21 CFR 868.5320 · Class 1
Overview
| Product Code | BTC |
|---|---|
| Device Name | Bag, Reservoir |
| Regulation | 21 CFR 868.5320 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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 | PeDIA | Pedia, LLC | Sep 25, 2018 | SESE |
| K940220 | REBREATHER BAGS | Zefon Medical Products | May 27, 1994 | SESE |
| K932584 | BREATHING BAGS | Merit Medical Systems, Inc. | Jul 16, 1993 | SESE |
| K932581 | BREATHING BAGS | Med-Plastics Intl., Inc. | Jul 16, 1993 | SESE |
| K932496 | PRECISION MED PRODUCTS, LTD. BREATHING BAGS | Precision Med Products, Ltd. | Jul 16, 1993 | SESE |
| K932191 | BREATHING BAGS | Life Shield Healthcare Products, Inc. | Jul 2, 1993 | SESE |
| K894906 | ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER | Med-Tek Corp. | Sep 18, 1989 | SESE |
| K880680 | KING SYSTEMS, BREATHING BAG | King Systems Corp. | Mar 3, 1988 | SESE |
| K864822 | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS | Surgidyne, Inc. | Jan 15, 1987 | SESE |
| K841412 | ROLLED NECK W/TAP | Warne Surgical Products, Ltd. | Apr 18, 1984 | SESE |
| K841411 | ROLLED NECK W/PLUG | Warne Surgical Products, Ltd. | Apr 18, 1984 | SESE |
| K830399 | COUPLING/VALVE | Khi, Inc. | Mar 10, 1983 | SESE |
| K830056 | ARTEC TWIST VALVE | Artec Environmental Monitoring Division | Mar 9, 1983 | SESE |
| K822216 | VOLUMETRIC CONTROLLER | Quest Medical, Inc. | Aug 16, 1982 | SESE |
| K822116 | ANESTHESIA BREATHING BAG, VARIOUS SIZES | Life Design Systems, Inc. | Aug 16, 1982 | SESE |
| K821309 | ESPREE', BREATHING BAG | Esp Plastics, Inc. | May 21, 1982 | SESE |
| K800155 | DISPOSAL LITER BREATHING BAG | Dryden Corp. | Feb 21, 1980 | SESE |
| K791910 | THREE LITER BAG #M-512 | Mem Medical, Inc. | Oct 9, 1979 | SESE |
| K791463 | 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
