Double Medical Technology, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Double Medical Technology, Inc.” (first 2016, latest 2025), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 248 days. Since 2017 the median was 238 days, against 90 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 |
|---|---|---|
| 2016 | 1 | 448 |
| 2017 | 0 | — |
| 2018 | 2 | 238 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 248 |
| 2023 | 5 | 272 |
| 2024 | 1 | 118 |
| 2025 | 1 | 82 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Double Medical Technology, Inc. took a median 238 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 3 | 3 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent Double Medical Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252729 | Universal Spinal System | NKB | 2025-11-18 | 82 |
| K242348 | Locking Screw,CoCrMo | HWC | 2024-12-04 | 118 |
| K233078 | Posterior Cervical Spine System | NKG | 2023-11-22 | 58 |
| K223753 | Cervical Plate System | KWQ | 2023-03-14 | 90 |
| K221150 | Advanced Bone Plate | HRS | 2023-01-25 | 280 |
| K221088 | Anatomic Bone Plate | HRS | 2023-01-18 | 280 |
| K221090 | Metal Cannulated Screw | HWC | 2023-01-10 | 272 |
| K221221 | Advanced Intramedullary Nail System | HSB | 2022-12-21 | 238 |
| K220921 | Metal Bone Screw | HWC | 2022-12-12 | 257 |
| K172830 | Double Medical Femoral Nail System | HSB | 2018-08-24 | 340 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Double Medical Technology, 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.
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.
- Double Hero Corp. (1 510(k)s)
- Double Scores , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Double Medical Technology, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Double Medical Technology, Inc.” (first 2016, latest 2025), across 8 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 Double Medical Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Double Medical Technology, Inc. is 248 days. Since 2017: 238 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Double Medical Technology, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 3); HRS (Plate, Fixation, Bone, 2); HSB (Rod, Fixation, Intramedullary And Accessories, 2).
Next steps
- See all 12 Double Medical Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Double Medical Technology, 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.