Deka Research and Development: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Deka Research and Development” (first 2015, latest 2026), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 106 days. Since 2017 the median was 102 days, against 208 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 |
|---|---|---|
| 2015 | 1 | 123 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 106 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 627 |
| 2024 | 8 | 94 |
| 2025 | 2 | 222 |
| 2026 | 2 | 26 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Deka Research and Development took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 208 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 4 | 4 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| LDR | Controller, Infusion, Intravascular, Electronic | 2 | 2 |
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | 2 | 2 |
| FKX | System, Peritoneal, Automatic Delivery | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 | 1 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 1 | 1 |
| QJI | Interoperable Automated Glycemic Controller | 1 | 1 |
Review panels
Most recent Deka Research and Development 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261672 | twiist Automated Insulin Delivery (AID) System | QFG | 2026-06-17 | 27 |
| K261530 | iiSure Infusion Set | FPA | 2026-06-03 | 26 |
| K243841 | Sparta Infusion Set for Insulin | FPA | 2025-08-01 | 231 |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | FRN | 2025-01-16 | 213 |
| K242693 | DEKA Infusion System, DEKA Administration Set | LDR | 2024-10-07 | 28 |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | KPO | 2024-07-12 | 99 |
| K233557 | HemoCare Hemodialysis System | KDI | 2024-07-12 | 249 |
| K240256 | Remunity System | QJY | 2024-06-12 | 133 |
| K241178 | DEKA ACE Pump System | QFG | 2024-05-24 | 25 |
| K234055 | DEKA Loop | QJI | 2024-03-13 | 82 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Deka Research and Development.
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 Deka Research and Development is the lead sponsor of 4 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07356089: Twiist Postmarket Surveillance Study for Type 1 Diabetes (Recruiting, started 2025-12-09)
- NCT06853990: Innovative Automated Insulin Delivery System for Type 2 Diabetes (Active not recruiting, started 2025-04-14)
- NCT04198012: An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System (Completed, started 2019-12-16)
- NCT04087213: Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD (Completed, started 2019-09-05)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Deka Research and Development (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Deka Research & Development Corp. (13 510(k)s)
- Deka R&D Corp (1 510(k)s)
- Deka Integrated Solutions Corporation (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Deka Research and Development?
FDA lists 15 510(k) clearances under the applicant name “Deka Research and Development” (first 2015, latest 2026), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Deka Research and Development?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deka Research and Development is 106 days. Since 2017: 102 days, versus 208 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Deka Research and Development?
The most frequent FDA product codes under this applicant name are QFG (Alternate Controller Enabled Insulin Infusion Pump, 4); FPA (Set, Administration, Intravascular, 2); LDR (Controller, Infusion, Intravascular, Electronic, 2).
Next steps
- See all 15 Deka Research and Development clearances with predicates and recalls
- Run predicate analysis for product code QFG, Deka Research and Development'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.