Clear Guide Medical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Clear Guide Medical” (first 2014, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Since 2017 the median was 90 days, against 126 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 |
|---|---|---|
| 2014 | 1 | 78 |
| 2015 | 0 | — |
| 2016 | 1 | 122 |
| 2017 | 1 | 185 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 90 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 28 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Clear Guide Medical took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 5 | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Radiology (6)
Most recent Clear Guide Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234030 | Clear Guide SCENERGY | JAK | 2024-01-17 | 28 |
| K201188 | Clear Guide SCENERGY | JAK | 2020-09-30 | 152 |
| K201898 | Clear Guide SCENERGY | JAK | 2020-07-31 | 29 |
| K171677 | Clear Guide SCENERGY | JAK | 2017-12-08 | 185 |
| K153004 | Clear Guide SCENERGY | JAK | 2016-02-12 | 122 |
| K141806 | CLEAR GUIDE ONE | IYO | 2014-09-19 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Clear Guide Medical.
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 Clear Guide Medical is the lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04039490: Novel Device for Ultrasound-guided Pediatric Vessel Cannulations (Recruiting, started 2024-02-06)
- NCT05889923: Training and Evaluation of Ultrasound-Guided Procedures (Completed, started 2021-08-16)
- NCT04031495: Image Guidance for Improved Vessel Cannulation in Pediatric Patients (Completed, started 2019-04-22)
- NCT02614222: Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks (Completed, started 2015-10-26)
- NCT02584673: Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement (Completed, started 2015-10)
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.
- Clear Choice Therapeutics (2 510(k)s)
- Clear Corp. (1 510(k)s)
- Clear Catheter Systems (1 510(k)s)
- Clear Moves Aligners (1 510(k)s)
- Clear Window Industrial, Ltd. (1 510(k)s)
- Clear Future, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clear Guide Medical?
FDA lists 6 510(k) clearances under the applicant name “Clear Guide Medical” (first 2014, latest 2024), 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 Clear Guide Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clear Guide Medical is 100 days. Since 2017: 90 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Clear Guide Medical?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 5); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Next steps
- See all 6 Clear Guide Medical clearances with predicates and recalls
- Run predicate analysis for product code JAK, Clear Guide Medical'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.