Associates of Cape Cod, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Associates of Cape Cod, Inc.” (first 2019, latest 2019), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 77 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 |
|---|---|---|
| 2019 | 1 | 77 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Associates of Cape Cod, Inc. took a median 77 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 77 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NQZ | Antigen, Invasive Fungal Pathogens | 2 | 1 |
Review panels
- Microbiology (2)
Most recent Associates of Cape Cod, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191167 | Fungitell STAT | NQZ | 2019-07-17 | 77 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN040003 | De Novo | Antigen, Invasive Fungal Pathogens | 2004-05-21 |
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2022-08-17.
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.
- Associates IN Biofeedback (1 510(k)s)
- Associates IN Radiology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Associates of Cape Cod, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Associates of Cape Cod, Inc.” (first 2019, latest 2019), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Associates of Cape Cod, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Associates of Cape Cod, Inc. is 77 days.
Which FDA product codes appear under Associates of Cape Cod, Inc.?
The most frequent FDA product codes under this applicant name are NQZ (Antigen, Invasive Fungal Pathogens, 2).
Next steps
- See all 1 Associates of Cape Cod, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NQZ, Associates of Cape Cod, 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.