Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NUP · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
234 daysmedian FDA review time
274 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213114 | BentrioTM Allergy Blocker | Altamira Therapeutics, Inc. | 2022-06-24 | 270 | 0 |
| K201734 | AllerBlock Junior | Nasaleze International, Ltd. | 2021-03-26 | 274 | 0 |
| K170848 | Alzair Allergy Blocker | Nasaleze International, Ltd. | 2017-06-14 | 85 | 0 |
| K134003 | RHINIX NASAL FILTER | Rhinix Aps | 2014-09-04 | 251 | 0 |
| K132520 | NASAL EASE ALLERGY BLOCKER | Hi-Tech Pharmacal, Inc. | 2013-12-31 | 141 | 0 |
| K120894 | HAYMAX | Haymax Limited | 2012-05-17 | 55 | 0 |
| K053625 | NASALGUARD | Trutek Corp | 2006-02-22 | 56 | 0 |
| K042610 | DR. THEISS ALERGOL POLLEN BLOCKER CREAM | Dr. Theiss Naturwaren GmbH | 2005-05-16 | 234 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda