Flashback Technologies, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Flashback Technologies, Inc.” (first 2018, latest 2022), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 235 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 |
|---|---|---|
| 2018 | 1 | 210 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 260 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Flashback Technologies, Inc. took a median 235 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 219 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PPW | Adjunctive Cardiovascular Status Indicator | 3 | 2 |
Review panels
- Cardiovascular (3)
Most recent Flashback Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213255 | CipherOx CRI Tablet | PPW | 2022-06-17 | 260 |
| K173929 | CipherOx CRI M1 | PPW | 2018-07-24 | 210 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160020 | De Novo | Adjunctive Cardiovascular Status Indicator | 2016-12-21 |
Recalls
openFDA lists no recalls under a recalling firm named Flashback 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.
Device clinical trials
An industry sponsor named Flashback Technologies, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02980471: Comparison of Compensatory Reserve Index to Changes in Stroke Volume and Intravascular Volume (Completed, started 2014-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Flashback Technologies, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Flashback Technologies, Inc.” (first 2018, latest 2022), 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 Flashback Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Flashback Technologies, Inc. is 235 days.
Which FDA product codes appear under Flashback Technologies, Inc.?
The most frequent FDA product codes under this applicant name are PPW (Adjunctive Cardiovascular Status Indicator, 3).
Next steps
- See all 2 Flashback Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PPW, Flashback 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.