DOWNS CAP FLOW GENERATOR
FDA 510(k) clearance K811393 · decided 1981-06-09
Clearance details
- K-number
- K811393
- Device name
- DOWNS CAP FLOW GENERATOR
- Applicant
- Vital Signs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-18
- Decision date
- 1981-06-09
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- BZR
- Device class
- 2
- Regulation number
- 868.5330
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- East Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| F&P Optiflow Air/Oxygen Flow Source (K243917) | Fisher & Paykel Healthcare, Ltd. | 2025-07-14 |
| Midas Flowmeter; eAVS (K241465) | Parker Hannifin Corporation | 2024-09-19 |
| Maxtec MaxBlend2+p (K231895) | Maxtec, LLC | 2023-12-04 |
| FlowStar Analog Mixer Flowmeter (K230987) | Baldus Sedation GmbH & Co. KG | 2023-09-14 |
| FlowStar Touch Digital Mixer Flowmeter (K222794) | Baldus Sedation GmbH & Co. KG | 2023-07-28 |
| Quality Mix Blender, Oxymixer (K221494) | Dehas Medical Systems GmbH | 2023-01-23 |
| Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (K202480) | Parker Hannifin | 2021-04-22 |
| Equinox Advantage (K173205) | O-Two Medical Technologies, Inc. | 2018-08-29 |
| MaxBlend 2, MaxBlend Lite (K161718) | Maxtec, LLC | 2016-10-27 |
| GMX Series Medical Air/Oxygen Blender (K142291) | Gentec (Shanghai) Corporation | 2015-05-19 |
| EQUINOX RELIEVE (K113687) | O-Two Medical Technologies, Inc. | 2012-04-30 |
| MAXMIXING BLOCK (K113232) | Maxtec, Inc. | 2012-03-01 |
Recalls involving this device
No recalls on record reference this clearance.