Kent Imaging, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Kent Imaging, Inc.” (first 2012, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 184 days. Since 2017 the median was 150 days, against 156 days for all cleared 510(k)s in the same product codes. 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 | 1 | 254 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 184 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 117 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 1 | 202 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kent Imaging, Inc. took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | 4 | 4 |
| QJF | Autofluorescence Imaging Adjunct Tool For Wounds | 1 | 1 |
Review panels
Most recent Kent Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242669 | SnapshotGLO (KB100) | QJF | 2025-03-26 | 202 |
| K240601 | SnapshotNIR model KD205 | MUD | 2024-04-02 | 29 |
| K201976 | SnapshotNIR | MUD | 2020-11-10 | 117 |
| K163070 | Kent Camera | MUD | 2017-05-05 | 184 |
| K113507 | KENT CAMERA | MUD | 2012-08-08 | 254 |
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2026-06-30.
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 Kent Imaging, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06237621: Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment (Recruiting, started 2024-02-12)
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.
- Kent Laboratories, Inc. (40 510(k)s)
- Kent Design & Manufacturing, Inc. (6 510(k)s)
- Kent Barker & Assoc. (1 510(k)s)
- Kent J. Toone, D.D.S. (1 510(k)s)
- Kent Medical Devices, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kent Imaging, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Kent Imaging, Inc.” (first 2012, latest 2025), across 2 product codes 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 Kent Imaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kent Imaging, Inc. is 184 days. Since 2017: 150 days, versus 156 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kent Imaging, Inc.?
The most frequent FDA product codes under this applicant name are MUD (Oximeter, Tissue Saturation, 4); QJF (Autofluorescence Imaging Adjunct Tool For Wounds, 1).
Next steps
- See all 5 Kent Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUD, Kent Imaging, 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.