Disposal Liter Breathing Bag
FDA 510(k) K800155 · Dryden Corp.
510(k) numberK800155
Submission
- Device name
- Disposal Liter Breathing Bag
- Applicant
- Dryden Corp.
Mchenry, IL, US - Received
- January 23, 1980
- Decision date
- February 21, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTC – Bag, Reservoir
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5320
- Specialty
- Anesthesiology
Other 510(k)s with product code BTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181424 | PeDIABTC · Traditional | Pedia, LLC | 09/25/2018SE |
| K940220 | Rebreather BagsBTC · Traditional | Zefon Medical Products | 05/27/1994SE |
| K932584 | Breathing BagsBTC · Traditional | Merit Medical Systems, Inc. | 07/16/1993SE |
| K932581 | Breathing BagsBTC · Traditional | Med-Plastics Intl., Inc. | 07/16/1993SE |
| K932496 | Precision Med Products, Ltd. Breathing BagsBTC · Traditional | Precision Med Products, Ltd. | 07/16/1993SE |
| K932191 | Breathing BagsBTC · Traditional | Life Shield Healthcare Products, Inc. | 07/02/1993SE |
| K894906 | Anesthesia Breathing Bags Sizes 1/2, 1,2,3 LiterBTC · Traditional | Med-Tek Corp. | 09/18/1989SE |
| K880680 | King Systems, Breathing BagBTC · Traditional | King Systems Corp. | 03/03/1988SE |
| K864822 | Varidyne 550, Models 12E,12M,24E & 24M Suction SysBTC · Traditional | Surgidyne, Inc. | 01/15/1987SE |
| K841412 | Rolled Neck W/TapBTC · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
More from Warne Surgical Products, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K880923 | Patient Ventilator IsolatorCBK · Traditional | 09/06/1988SE |
| K880769 | Breathing Circuit W/Heated WireBZE · Traditional | 08/24/1988SE |
| K882285 | Nonrebreathing CircuitBTM · Traditional | 08/16/1988SE |
| K873928 | Universal TourniquetGAX · Traditional | 10/23/1987SE |
| K873927 | Reuseable Breathing TubesBZO · Traditional | 10/20/1987SE |
| K870859 | Bag-Tail Bleed ValveCAI · Traditional | 08/03/1987SE |
| K871386 | Breathing CircuitCAI · Traditional | 05/29/1987SE |
| K870858 | Badgwell Sampling CatheterCCK · Traditional | 05/14/1987SE |
| K861540 | Disposable Berman and Guedel AirwaysCAE · Traditional | 05/02/1986SE |
| K850644 | Nasopharyngeal Airway-RobertazziBTQ · Traditional | 03/21/1985SE |
Questions and answers
When was Disposal Liter Breathing Bag cleared by the FDA?
Disposal Liter Breathing Bag (K800155) received a 510(k) decision of Substantially Equivalent on February 21, 1980, 29 days after the submission was received.
What is the product code of K800155?
The FDA product code is BTC – Bag, Reservoir, a Class I (low risk) device regulated under 21 CFR 868.5320.