Panels › Anesthesiology › Product code BTC · Class 1
Bag, Reservoir
Regulation 868.5320
0510(k)s in 12 months (19 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in BTC
| Company | 510(k)s | Recalls |
|---|---|---|
| Medline Industries Inc | 0 | 3 |
| Draeger Medical, Inc. | 0 | 2 |
| Warne Surgical Products, Ltd. | 2 | 0 |
| Artec Environmental Monitoring Division | 1 | 0 |
| Cameron Medical Corp. | 1 | 0 |
| Dryden Corp. | 1 | 0 |
| Esp Plastics, Inc. | 1 | 0 |
| Khi, Inc. | 1 | 0 |
| King Systems Corp. | 1 | 0 |
| Life Design Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2018 | K181424 | PeDIA Pedia, LLC | BTC |
| May 27, 1994 | K940220 | REBREATHER BAGS Zefon Medical Products | BTC |
| Jul 16, 1993 | K932584 | BREATHING BAGS Merit Medical Systems, Inc. | BTC |
| Jul 16, 1993 | K932581 | BREATHING BAGS Med-Plastics Intl., Inc. | BTC |
| Jul 16, 1993 | K932496 | PRECISION MED PRODUCTS, LTD. BREATHING BAGS Precision Med Products, Ltd. | BTC |
| Jul 2, 1993 | K932191 | BREATHING BAGS Life Shield Healthcare Products, Inc. | BTC |
| Sep 18, 1989 | K894906 | ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER Med-Tek Corp. | BTC |
| Mar 3, 1988 | K880680 | KING SYSTEMS, BREATHING BAG King Systems Corp. | BTC |
| Jan 15, 1987 | K864822 | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS Surgidyne, Inc. | BTC |
| Apr 18, 1984 | K841412 | ROLLED NECK W/TAP Warne Surgical Products, Ltd. | BTC |
| Apr 18, 1984 | K841411 | ROLLED NECK W/PLUG Warne Surgical Products, Ltd. | BTC |
| Mar 10, 1983 | K830399 | COUPLING/VALVE Khi, Inc. | BTC |
| Mar 9, 1983 | K830056 | ARTEC TWIST VALVE Artec Environmental Monitoring Division | BTC |
| Aug 16, 1982 | K822216 | VOLUMETRIC CONTROLLER Quest Medical, Inc. | BTC |
| Aug 16, 1982 | K822116 | ANESTHESIA BREATHING BAG, VARIOUS SIZES Life Design Systems, Inc. | BTC |
| May 21, 1982 | K821309 | ESPREE', BREATHING BAG Esp Plastics, Inc. | BTC |
| Feb 21, 1980 | K800155 | DISPOSAL LITER BREATHING BAG Dryden Corp. | BTC |
| Oct 9, 1979 | K791910 | THREE LITER BAG #M-512 Mem Medical, Inc. | BTC |
| Sep 17, 1979 | K791463 | PARA-VENT Cameron Medical Corp. | BTC |
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