Hologic, Inc.: FDA clearances and approvals
Hologic, Inc. has 118 FDA 510(k) clearances (first 1987, latest 2026), plus 18 PMA and 2 De Novo decisions, across 46 product codes in 8 review panels. Median 510(k) review time: 87 days. Since 2017 its median was 105 days, against 123 days for all cleared 510(k)s in the same product codes. openFDA lists 63 product recalls by a recalling firm named Hologic, Inc. It is the industry lead sponsor of 16 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 9 | 34 |
| 2013 | 6 | 90 |
| 2014 | 3 | 74 |
| 2015 | 4 | 42 |
| 2016 | 2 | 92 |
| 2017 | 7 | 94 |
| 2018 | 6 | 108 |
| 2019 | 7 | 104 |
| 2020 | 4 | 50 |
| 2021 | 0 | — |
| 2022 | 2 | 130 |
| 2023 | 5 | 182 |
| 2024 | 6 | 101 |
| 2025 | 5 | 99 |
| 2026 | 3 | 210 |
Review time against the same product codes
Since 2017, Hologic, Inc.'s cleared 510(k)s took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGI | Densitometer, Bone | 29 | 29 |
| HIH | Hysteroscope (And Accessories) | 13 | 13 |
| LLZ | System, Image Processing, Radiological | 13 | 13 |
| IZH | System, X-Ray, Mammographic | 6 | 6 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 5 | 4 |
| KNW | Instrument, Biopsy | 4 | 4 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 4 | 2 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 4 | 4 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 4 | 4 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 3 | 3 |
Plus 36 more product codes.
Review panels
- Radiology (69)
- Microbiology (32)
- Obstetrics and Gynecology (17)
- Pathology (6)
- General and Plastic Surgery (6)
- General Hospital (3)
- Clinical Chemistry (2)
- Hematology (2)
Most recent Hologic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254090 | I-View® | MUE | 2026-09-02 | 257 |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | KNW | 2026-08-12 | 6 |
| K253634 | CoolSeal Generator® (CSL-200-90) | GEI | 2026-06-17 | 210 |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | PCH | 2025-09-25 | 90 |
| K251868 | Panther Fusion GI Bacterial Assay | PCH | 2025-09-25 | 99 |
| K243341 | Genius AI Detection 2.0 | QDQ | 2025-07-31 | 279 |
| K243396 | Aptima SARS-CoV-2 Assay | QQX | 2025-02-13 | 105 |
| K243935 | Aptima CMV Quant Assay | PAB | 2025-01-17 | 28 |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | PQA | 2024-11-25 | 28 |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | QOF | 2024-11-15 | 87 |
108 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210035 | De Novo | Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm | 2024-01-31 |
| P210029 | PMA | Aptima CMV Quant Assay | 2022-05-09 |
| DEN180047 | De Novo | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 2019-01-23 |
| P170025 | PMA | Aptima HBV Quant Assay | 2018-01-23 |
| P160023 | PMA | APTIMA HCV QUANT DX ASSAY | 2017-02-13 |
Recalls
63 product recalls in 49 recall events; 22 initiated in the last five years. Most recent: 2026-04-08.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Hologic, Inc. is the industry lead sponsor of 16 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06636539: Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device (Recruiting, started 2024-10-14)
- NCT05199701: Prospective Case Collection Study for New Mammography Technologies (Recruiting, started 2021-12-10)
- NCT04671329: A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy (Completed, started 2021-03-05)
- NCT03456583: Brevera™ Breast Biopsy System Data Collection Study (Completed, started 2017-11-20)
- NCT03300206: A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System (Completed, started 2017-09-13)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Hologic, Inc.'s product codes (a text match, not an official crosswalk):
- A4648 — Tissue marker, implantable, any type, each (via NEU)
- G0279 — Diagnostic digital breast tomosynthesis, unilateral or bilateral (list separately in addition to 77065 or 77066) (via OTE)
Frequently asked questions
How many FDA 510(k) clearances does Hologic, Inc. have?
Hologic, Inc. has 118 FDA 510(k) clearances (first 1987, latest 2026), plus 18 PMA and 2 De Novo decisions, across 46 product codes in 8 review panels.
How long does FDA take to clear Hologic, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hologic, Inc.'s cleared 510(k)s is 87 days. Since 2017: 105 days, versus 123 days for all cleared 510(k)s in the same product codes.
What devices does Hologic, Inc. make?
Its most frequent FDA product codes are KGI (Densitometer, Bone, 29); HIH (Hysteroscope (And Accessories), 13); LLZ (System, Image Processing, Radiological, 13).
Has Hologic, Inc. had device recalls?
openFDA lists 63 product recalls in 49 recall events by a recalling firm whose name matches Hologic, Inc; the most recent began 2026-04-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 118 Hologic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGI, Hologic, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.