Prism Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Prism Technologies, Inc.” (first 1991, latest 1998), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 106 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 |
|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | 4 | 4 |
| HDB | Extractor, Vacuum, Fetal | 1 | 1 |
Review panels
Most recent Prism Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980212 | MITYVAC | HDB | 1998-07-09 | 169 |
| K953542 | COLDGEL | IMD | 1995-10-30 | 94 |
| K953541 | INSTANT COLDGEL | IMD | 1995-10-05 | 69 |
| K934631 | TRANSWARMER | IMD | 1994-02-03 | 132 |
| K912715 | INSTANT WARM GEL PACK | IMD | 1991-10-02 | 106 |
Recalls
openFDA lists no recalls under a recalling firm named Prism Technologies, Inc..
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.
- Prism Enterprises, Inc. (4 510(k)s)
- Prism Imaging, Inc. (4 510(k)s)
- Prism Clinical Imaging, Inc. (2 510(k)s)
- Prism Surgical Design Pty , Ltd. (1 510(k)s)
- Prism Surgical Designs Pty, Ltd. (1 510(k)s)
- Prism Therapeutics, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Prism Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Prism Technologies, Inc.” (first 1991, latest 1998), across 2 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 Prism Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prism Technologies, Inc. is 106 days.
Which FDA product codes appear under Prism Technologies, Inc.?
The most frequent FDA product codes under this applicant name are IMD (Pack, Hot Or Cold, Disposable, 4); HDB (Extractor, Vacuum, Fetal, 1).
Next steps
- See all 5 Prism Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IMD, Prism Technologies, 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.