510(k) · Cleared
ClearedNasalguard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trutek Corp · NUP Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Cleared on Feb 22, 2006 as substantially equivalent to K042610 (Dr. Theiss Naturwaren GmbH, 2005) after a 56-day review. Its family tree reaches back 4 generations to 2001. 6 later devices descend from it.
- Decided
- Feb 22, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- NUP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002338 (2001). 6 ancestors in all, the oldest K872359 (1987). 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK002338 Liquiderm Liquid Adhesive BandageClosure Medical Corp. · 2001
- 3 generations backK022645 CURADBeiersdorf AG · 2002
- 2 generations backK032948 Elastic Skin Liquid BandageMedpak, LLC · 2004
- 1 generation backK042610 DR. Theiss Alergol Pollen Blocker CreamDr. Theiss Naturwaren GmbH · 2005
- This deviceK053625 NasalguardTrutek Corp · 2006
- Descendant · cites it directly · 3 of its ownK132520 Nasal Ease Allergy BlockerHi-Tech Pharmacal, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK170848 Alzair Allergy BlockerNasaleze International, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK120894 HaymaxHaymax Limited · 2012
- Descendant · 2 generations on · 0 of its ownK213114 BentrioTM Allergy BlockerAltamira Therapeutics, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK201734 AllerBlock JuniorNasaleze International, Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132520Nasal Ease Allergy BlockerHi-Tech Pharmacal, Inc. · 2013 · cites it directly3descendants
- K170848Alzair Allergy BlockerNasaleze International, Ltd. · 2017 · 2 generations on1descendant
- K120894HaymaxHaymax Limited · 2012 · cites it directly1descendant
- K213114BentrioTM Allergy BlockerAltamira Therapeutics, Inc. · 2022 · 2 generations on0descendants
- K201734AllerBlock JuniorNasaleze International, Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002338 | Liquiderm Liquid Adhesive Bandage | Closure Medical Corp. | 2001 | — |
| −3 | K022645 | CURAD | Beiersdorf AG | 2002 | — |
| −2 | K032948 | Elastic Skin Liquid Bandage | Medpak, LLC | 2004 | — |
| −1 | K042610 | DR. Theiss Alergol Pollen Blocker Cream | Dr. Theiss Naturwaren GmbH | 2005 | — |
| 0 (this device) | K053625 | Nasalguard | Trutek Corp | 2006 | — |
| +1 | K132520 | Nasal Ease Allergy Blocker | Hi-Tech Pharmacal, Inc. | 2013 | — |
| +2 | K170848 | Alzair Allergy Blocker | Nasaleze International, Ltd. | 2017 | — |
| +1 | K120894 | Haymax | Haymax Limited | 2012 | — |
| +2 | K213114 | BentrioTM Allergy Blocker | Altamira Therapeutics, Inc. | 2022 | — |
| +3 | K201734 | AllerBlock Junior | Nasaleze International, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 K213114 BentrioTM Allergy Blockerscore 5.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K042610 | DR. Theiss Alergol Pollen Blocker CreamSummary page 1…anufacturer Device Approval 510(K) ~~~~~~~~~~~Date K042610 Dr. Theiss Naturwaren Dr.Theiss Alergol 05/1620 Gmbh, Germany Polle… | 2005 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K132520 (Hi-Tech Pharmacal, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K042610.
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.
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?
NasalGuard® is intended to promote alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny or congested nasal passages) triggered by the inhalation of various allergens including environmental pollens, house dust, animal hairs and dust mites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053625: Nasalguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053625
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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