510(k) · Cleared
ClearedRhinix Nasal Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhinix Aps · NUP Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Cleared on Sep 4, 2014 as substantially equivalent to K120894 (Haymax Limited, 2012) after a 251-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Sep 4, 2014
- Review
- 251 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 backK120894 HaymaxHaymax Limited · 2012
- This deviceK134003 Rhinix Nasal FilterRhinix Aps · 2014
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 | K120894 | Haymax | Haymax Limited | 2012 | — |
| 0 (this device) | K134003 | Rhinix Nasal Filter | Rhinix Aps | 2014 | — |
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 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 |
|---|---|---|---|
| * | K120894 | HaymaxSummary page 4…filter Classification name: Recirculating Air Filter (NUP) Predicate devices: 510(k) or reg. no Manufacturer Device Product Code K120894 HayMaxTM Limited, HaymaxTM Organic NUP Bedfordshire, UK Drug-Fre… | 2012 |
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 13 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.
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. 2014, 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?
RHINIX™ nasal filter for patients aged 6 years and older, with properties that allow unimpeded nasal breathing, is for the prevention or alleviation of seasonal allergic rhinitis (hay fever) and for seasonal or perennial allergies to other airborne allergens with a similar size fraction to grass pollen allergens.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K134003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134003: Rhinix Nasal Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134003
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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