Minineb
by Vortran Medical Technology 1 Inc.
510(k) K920443
Minineb is a medical device (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Vortran Medical Technology 1 Inc., cleared under FDA 510(k) K920443 on 2 Jul 1992, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920443 | Date2 Jul 1992 | StatusActive |
Official records
- FDA 510(k) database K920443
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CAF
- FDA applicant
- Vortran Medical Technology 1, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K920443
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| *Mini-Heart® Lo-Flo Continuous Nebulizer W/Extension Set, 7' 100616 | 100616 | 00709078000218 | — | No longer on the market |
| Mini-Heart 100625 | 100625 | 00709078008191 | — | On the market |
| Mini-Heart ®Hi-Flo Continuous Nebulizer, Swivel Adaptor 100615 | 100615 | 00709078000270 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).
- Nebulizing Elbow Standard Elbow, Nebulizing Elbow Kit 1119038 by Respironics Inc.
- OxyMulti Kid Ultra™ OKHH-1025-8 by Southmedic Incorporated
- HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 by Pegasus Research Corp.
- Omron Ultrasonic Nebulizer NE-U06 by Nidek, Inc.
- Aerosol Masks 81426, 81476, 81490 & 81492 by Specialty Packaging Producs, Inc.
- MDILOG, MODEL MDC-511 by Medtrak Technologies, Inc.
- 3ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution Usp by Steripak, Ltd.
- Maxineb Duo Nebulizer + Mouthpiece And Filter 032-10-034U by FLEXICARE MEDICAL LIMITED
- OptiChamber Advantage Anti-Static Valved Holding Chamber by Respironics New Jersey, Inc.
- Hailie Sensor by Adherium (Nz), Ltd.