Dilon Technologies, Inc.: FDA clearances and approvals
Dilon Technologies, Inc. has 3 FDA 510(k) clearances (first 1999, latest 2011), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time: 90 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | 3 | 3 |
| PMX | Absorbable Collagen Hemostatic Agent With Thrombin | 1 | 0 |
Review panels
Most recent Dilon Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110384 | DILON 6800 ACELLA (ACELLA) | IYX | 2011-05-03 | 82 |
| K082588 | GAMMALOC SYSTEM, MODEL 03-00001 | IYX | 2009-12-11 | 459 |
| K984466 | DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 | IYX | 1999-03-16 | 90 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170012 | PMA | HEMOBLAST Bellows | 2017-12-15 |
Recalls
openFDA lists no recalls under a recalling firm named Dilon Technologies, 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
Dilon Technologies, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04734535: Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery (Completed, started 2021-03-08)
Frequently asked questions
How many FDA 510(k) clearances does Dilon Technologies, Inc. have?
Dilon Technologies, Inc. has 3 FDA 510(k) clearances (first 1999, latest 2011), plus 1 PMA decision, across 2 product codes in 2 review panels.
How long does FDA take to clear Dilon Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dilon Technologies, Inc.'s cleared 510(k)s is 90 days.
What devices does Dilon Technologies, Inc. make?
Its most frequent FDA product codes are IYX (Camera, Scintillation (Gamma), 3); PMX (Absorbable Collagen Hemostatic Agent With Thrombin, 1).
Has Dilon Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dilon Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 3 Dilon Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYX, Dilon Technologies, 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.