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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Hycor Biomedical · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

127 daysmedian FDA review time
148 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (GHycor Biomedical2026-07-241160
K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame SeedHycor Biomedical2026-07-211480
K260280NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (TriHycor Biomedical2026-06-181400
K260059NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil NutHycor Biomedical2026-05-151270
K252775NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (ArHycor Biomedical2026-01-161360
K252493NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (ShHycor Biomedical2025-12-231370
K242531NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, JohnHycor Biomedical2025-04-232400
K220162Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), CaHycor Biomedical2022-02-18290
K200825NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E00Hycor Biomedical2020-06-26880
K191510Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), CaHycor Biomedical2019-07-31550
K182479NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) AssaHycor Biomedical2018-12-04850

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