Spectralmd, Inc.: FDA clearances and approvals
Spectralmd, Inc. has 2 FDA 510(k) clearances (first 2013, latest 2017), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time: 185 days. It is the industry lead sponsor of 5 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 108 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 262 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Spectralmd, Inc.'s cleared 510(k)s took a median 262 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 254 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | 2 | 2 |
| SHY | Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment. | 1 | 0 |
Review panels
Most recent Spectralmd, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163339 | SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 | DPT | 2017-08-17 | 262 |
| K124049 | DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM | DPT | 2013-04-18 | 108 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250028 | De Novo | Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment. | 2026-05-21 |
Recalls
openFDA lists no recalls under a recalling firm named Spectralmd, 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.
Device clinical trials
Spectralmd, Inc. is the industry lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06131203: Burn Validation Study (Completed, started 2023-12-19)
- NCT06024512: DeepView Snapshot Handheld (DV-H) Comparison Study (Completed, started 2023-06-13)
- NCT05581966: Wound Assessment Using Spectral Imaging EU/UK (Completed, started 2023-03-15)
- NCT05415683: Wound Assessment Using Spectral Imaging US (Completed, started 2022-06-22)
- NCT05023135: DeepView SnapShot Portable (DV-SSP): Device Training Study (Completed, started 2021-09-07)
Frequently asked questions
How many FDA 510(k) clearances does Spectralmd, Inc. have?
Spectralmd, Inc. has 2 FDA 510(k) clearances (first 2013, latest 2017), plus 1 De Novo decision, across 2 product codes in 2 review panels.
How long does FDA take to clear Spectralmd, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Spectralmd, Inc.'s cleared 510(k)s is 185 days.
What devices does Spectralmd, Inc. make?
Its most frequent FDA product codes are DPT (Probe, Blood-Flow, Extravascular, 2); SHY (Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment., 1).
Has Spectralmd, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Spectralmd, Inc. Related entities may recall under other names.
Next steps
- See all 2 Spectralmd, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPT, Spectralmd, 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.