Humagen Fertility Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Humagen Fertility Diagnostics, Inc.” (first 1994, latest 2002), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 121 days. 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 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQH | Microtools, Assisted Reproduction (Pipettes) | 2 | 2 |
| MQK | Labware, Assisted Reproduction | 2 | 2 |
| POV | Semen Analysis Device | 1 | 1 |
Review panels
Most recent Humagen Fertility Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012811 | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B | MQH | 2002-02-11 | 173 |
| K000915 | PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 | MQK | 2000-05-12 | 51 |
| K990941 | NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L | MQK | 1999-07-14 | 114 |
| K990847 | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M | MQH | 1999-07-14 | 121 |
| K915229 | SEMEN ANALYSIS KIT | POV | 1994-08-30 | 1014 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-05-08.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Humagen, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Humagen Fertility Diagnostics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Humagen Fertility Diagnostics, Inc.” (first 1994, latest 2002), across 3 product codes in 2 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 Humagen Fertility Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Humagen Fertility Diagnostics, Inc. is 121 days.
Which FDA product codes appear under Humagen Fertility Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are MQH (Microtools, Assisted Reproduction (Pipettes), 2); MQK (Labware, Assisted Reproduction, 2); POV (Semen Analysis Device, 1).
Next steps
- See all 5 Humagen Fertility Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQH, Humagen Fertility Diagnostics, 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.