510(k) · Cleared

Cleared

Haymax

K120894510(k) TraditionalCleared May 17, 201255-day reviewClass II21 CFR 880.5045

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Haymax Limited · NUP Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

Cleared on May 17, 2012 as substantially equivalent to K053625 (Trutek Corp, 2006) and 1 other predicate after a 55-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.

Decided: May 17, 2012
Review: 55 days
Class: Class II
Product code: NUP
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K002338 (2001). 7 ancestors in all, the oldest K872359 (1987). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK002338 Liquiderm Liquid Adhesive BandageClosure Medical Corp. · 2001
4 generations backK022645 CURADBeiersdorf AG · 2002
3 generations backK032948 Elastic Skin Liquid BandageMedpak, LLC · 2004
2 generations backK042610 DR. Theiss Alergol Pollen Blocker CreamDr. Theiss Naturwaren GmbH · 2005
1 generation backK053625 NasalguardTrutek Corp · 2006
This deviceK120894 HaymaxHaymax Limited · 2012
Descendant · cites it directly · 0 of its ownK134003 Rhinix Nasal FilterRhinix Aps · 2014

Most influential descendants

Showing 1 of 1 · See all

K134003Rhinix Nasal FilterRhinix Aps · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K002338	Liquiderm Liquid Adhesive Bandage	Closure Medical Corp.	2001	—
−4	K022645	CURAD	Beiersdorf AG	2002	—
−3	K032948	Elastic Skin Liquid Bandage	Medpak, LLC	2004	—
−2	K042610	DR. Theiss Alergol Pollen Blocker Cream	Dr. Theiss Naturwaren GmbH	2005	—
−1	K053625	Nasalguard	Trutek Corp	2006	—
0 (this device)	K120894	Haymax	Haymax Limited	2012	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K120894, 2001–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K053625	Nasalguard Summary page 1 …Unclassified Predicate Devices 510(K) Manufacturer Device Approval Date K(053625 Turtech NasalGuard® 02/22/2006 Corporation,…	Trutek Corp	2006	—
*	K042610	DR. Theiss Alergol Pollen Blocker Cream Summary page 1 …te K(053625 Turtech NasalGuard® 02/22/2006 Corporation, USA K(042610 Dr Theiss Dr Theiss Alergol -05/16/2005 Naturwaren…	Dr. Theiss Naturwaren GmbH	2005	—

Also cleared against K053625: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K134003	Rhinix Nasal Filter	Rhinix Aps	2014	0

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 11 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K134003 (Rhinix Aps, 2014) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K053625.

How does its category compare?

All NUP devices

NUP Cream, Nasal, Topical, Mechanical Allergen Particle Barrier: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · NUP

1in 2022

2007high 1 (2012) · low 0 (2007)2026

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

2007high 1 (2020) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	1	—	0
2014	1	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	1
2021	1	—	0
2022	1	—	0
2023	0	—	0
2024	0	—	1
2025	0	—	0
2026	0	—	—

What is it indicated for?

HayMax m organic pollen barrier balm is intended to promote alleviation of mild allergic symptons, (iLe, mild nasal irritation, including itchy, runny, or congested nasal passages), triggered by the inhalation of various airborne allergens including grass and tree pollen, house dust mite and animal dander.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120894 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120894: Haymax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120894

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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