Hycor Biomedical, Inc.: FDA filings under this applicant name
FDA lists 66 510(k) clearances under the applicant name “Hycor Biomedical, Inc.” (first 1989, latest 2026), across 24 product codes in 4 review panels. Median 510(k) review time under this name: 114 days. Since 2017 the median was 127 days, against 148 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 85 |
| 2019 | 1 | 55 |
| 2020 | 1 | 88 |
| 2021 | 0 | — |
| 2022 | 1 | 29 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 188 |
| 2026 | 5 | 136 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hycor Biomedical, Inc. took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 24 | 24 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 10 | 10 |
| DKB | Calibrators, Drug Mixture | 3 | 3 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 3 | 3 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 2 | 2 |
| LKJ | Antinuclear Antibody, Antigen, Control | 2 | 2 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | 2 |
| LYR | Helicobacter Pylori | 2 | 2 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | 2 |
Plus 14 more product codes.
Review panels
- Immunology (53)
- Clinical Toxicology (9)
- Clinical Chemistry (2)
- Microbiology (2)
Most recent Hycor Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut | DHB | 2026-07-24 | 116 |
| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut | DHB | 2026-07-21 | 148 |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | DHB | 2026-06-18 | 140 |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) | DHB | 2026-05-15 | 127 |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg | DHB | 2026-01-16 | 136 |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) | DHB | 2025-12-23 | 137 |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz | DHB | 2025-04-23 | 240 |
| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria | DHB | 2022-02-18 | 29 |
| K200825 | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense | DHB | 2020-06-26 | 88 |
| K191510 | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae | DHB | 2019-07-31 | 55 |
56 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2018-07-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hycor Biomedical, Inc.?
FDA lists 66 510(k) clearances under the applicant name “Hycor Biomedical, Inc.” (first 1989, latest 2026), across 24 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hycor Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hycor Biomedical, Inc. is 114 days. Since 2017: 127 days, versus 148 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hycor Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 24); LLL (Extractable Antinuclear Antibody, Antigen And Control, 10); DKB (Calibrators, Drug Mixture, 3).
Next steps
- See all 66 Hycor Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DHB, Hycor Biomedical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.