Breathing Bags
FDA 510(k) K932584 · Merit Medical Systems, Inc.
510(k) numberK932584
Submission
- Device name
- Breathing Bags
- Applicant
- Merit Medical Systems, Inc.
Indianapolis, IN, US - Received
- May 27, 1993
- Decision date
- July 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K841411 | Rolled Neck W/PlugBTC · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
More from Warne Surgical Products, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | 07/27/2026SE |
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | 07/22/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | 05/13/2026SE |
| K251802 | STAR RF Ablation SystemGXI · Traditional | 02/13/2026SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | 12/19/2025SE |
| K250853 | Merit SyringeFMF · Special | 11/04/2025SE |
| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | 07/23/2025SE |
| K250909 | Prelude Wave Hydrophilic Sheath IntroducerDYB · Special | 04/25/2025SE |
| K242873 | Ventrax Delivery SystemDQY · Special | 01/15/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | 01/15/2025SE |
Questions and answers
When was Breathing Bags cleared by the FDA?
Breathing Bags (K932584) received a 510(k) decision of Substantially Equivalent on July 16, 1993, 50 days after the submission was received.
What is the product code of K932584?
The FDA product code is BTC – Bag, Reservoir, a Class I (low risk) device regulated under 21 CFR 868.5320.