Shandon, Inc.: FDA clearances and approvals
Shandon, Inc. has 5 FDA 510(k) clearances (first 1978, latest 1989), across 4 product codes in 1 review panel. Median 510(k) review time: 36 days.
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 |
|---|---|---|---|
| HYB | Eosin Y | 2 | 2 |
| HYK | Hematoxylin Harris'S | 1 | 1 |
| KIM | Device For Sealing Microsections | 1 | 1 |
| KIO | Slide Stainer, Immersion Type | 1 | 1 |
Review panels
- Pathology (5)
Most recent Shandon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893663 | INSTANT EOSIN-AQUEOUS | HYB | 1989-06-13 | 29 |
| K890984 | LINISTAIN SLS | KIO | 1989-04-04 | 36 |
| K880240 | INSTANT EOSIN-ALCOHOLIC | HYB | 1988-03-03 | 43 |
| K873107 | INSTANT HEMATOXYLIN | HYK | 1987-08-21 | 14 |
| K780261 | COVERSLIPPER | KIM | 1978-04-18 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Shandon, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Shandon, Inc. have?
Shandon, Inc. has 5 FDA 510(k) clearances (first 1978, latest 1989), across 4 product codes in 1 review panel.
How long does FDA take to clear Shandon, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Shandon, Inc.'s cleared 510(k)s is 36 days.
What devices does Shandon, Inc. make?
Its most frequent FDA product codes are HYB (Eosin Y, 2); HYK (Hematoxylin Harris'S, 1); KIM (Device For Sealing Microsections, 1).
Has Shandon, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Shandon, Inc. Related entities may recall under other names.
Next steps
- See all 5 Shandon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HYB, Shandon, 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.