510(k) · Cleared
ClearedBentrioTM Allergy Blocker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altamira Therapeutics, Inc. · NUP Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Cleared on Jun 24, 2022 as substantially equivalent to K132520 (Hi-Tech Pharmacal, Inc., 2013) after a 270-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jun 24, 2022
- Review
- 270 days
- Class
- Class II
- Product code
- NUP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002338 (2001). 8 ancestors in all, the oldest K872359 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK002338 Liquiderm Liquid Adhesive BandageClosure Medical Corp. · 2001
- 5 generations backK022645 CURADBeiersdorf AG · 2002
- 4 generations backK032948 Elastic Skin Liquid BandageMedpak, LLC · 2004
- 3 generations backK042610 DR. Theiss Alergol Pollen Blocker CreamDr. Theiss Naturwaren GmbH · 2005
- 2 generations backK053625 NasalguardTrutek Corp · 2006
- 1 generation backK132520 Nasal Ease Allergy BlockerHi-Tech Pharmacal, Inc. · 2013
- This deviceK213114 BentrioTM Allergy BlockerAltamira Therapeutics, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002338 | Liquiderm Liquid Adhesive Bandage | Closure Medical Corp. | 2001 | — |
| −5 | K022645 | CURAD | Beiersdorf AG | 2002 | — |
| −4 | K032948 | Elastic Skin Liquid Bandage | Medpak, LLC | 2004 | — |
| −3 | K042610 | DR. Theiss Alergol Pollen Blocker Cream | Dr. Theiss Naturwaren GmbH | 2005 | — |
| −2 | K053625 | Nasalguard | Trutek Corp | 2006 | — |
| −1 | K132520 | Nasal Ease Allergy Blocker | Hi-Tech Pharmacal, Inc. | 2013 | — |
| 0 (this device) | K213114 | BentrioTM Allergy Blocker | Altamira Therapeutics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NUP device
- #1 K201734 AllerBlock Juniorscore 2.9 · 7 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132520 | Nasal Ease Allergy BlockerSummary page 4…fication Name: Cream, Nasal, Topical, Mechanical Allergen Particle Barrier CFR Reference: 21 CFR 880.5045 Product Code: NUP Regulatory Class: Class II Predicate Device K132520 – Nasal Ease Allergy Blocker, Hi-Tech Pharmacal, Inc. Product Description BentrioTM is a gel emulsion which is applied as a nas… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K132520.
How does its category compare?
All NUP devicesNUP Cream, Nasal, Topical, Mechanical Allergen Particle Barrier: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NUP
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NUP
Too few NUP 510(k)s in any year since 2007 to give a median.
Recalls per year · NUP
No recall names NUP since 2007.
Adverse event reports per year · NUP
1in 2024
MAUDE reports naming product code NUP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Bentrio is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hair and dust mites.
Application of Bentrio produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213114: BentrioTM Allergy Blocker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213114
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026