BentrioTM Allergy Blocker
FDA 510(k) clearance K213114 · decided 2022-06-24
Clearance details
- K-number
- K213114
- Device name
- BentrioTM Allergy Blocker
- Applicant
- Altamira Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-27
- Decision date
- 2022-06-24
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- NUP
- Device class
- 2
- Regulation number
- 880.5045
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dover, DE, 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 |
|---|---|---|
| AllerBlock Junior (K201734) | Nasaleze International, Ltd. | 2021-03-26 |
| Alzair Allergy Blocker (K170848) | Nasaleze International, Ltd. | 2017-06-14 |
| RHINIX NASAL FILTER (K134003) | Rhinix Aps | 2014-09-04 |
| NASAL EASE ALLERGY BLOCKER (K132520) | Hi-Tech Pharmacal, Inc. | 2013-12-31 |
| HAYMAX (K120894) | Haymax Limited | 2012-05-17 |
| NASALGUARD (K053625) | Trutek Corp | 2006-02-22 |
| DR. THEISS ALERGOL POLLEN BLOCKER CREAM (K042610) | Dr. Theiss Naturwaren GmbH | 2005-05-16 |
Recalls involving this device
No recalls on record reference this clearance.