Deka Research & Development Corp.: FDA filings under this applicant name

FDA lists 13 510(k) clearances under the applicant name “Deka Research & Development Corp.” (first 1984, latest 2025), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 63 days, against 213 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Deka Research & Development Corp. took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 213 days.

Top product codes

Review panels

• General Hospital (8)
• Gastroenterology and Urology (3)
• Clinical Chemistry (1)
• Physical Medicine (1)

Most recent Deka Research & Development Corp. 510(k) clearances

3 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Deka Research & Development Corp..

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.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Deka Research & Development Corp. (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 and Development (15 510(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 & Development Corp.?

FDA lists 13 510(k) clearances under the applicant name “Deka Research & Development Corp.” (first 1984, latest 2025), across 8 product codes in 4 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 & Development Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Deka Research & Development Corp. is 94 days. Since 2017: 63 days, versus 213 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Deka Research & Development Corp.?

The most frequent FDA product codes under this applicant name are LDR (Controller, Infusion, Intravascular, Electronic, 3); FKX (System, Peritoneal, Automatic Delivery, 2); FRN (Pump, Infusion, 2).

Next steps

• See all 13 Deka Research & Development Corp. clearances with predicates and recalls
• Run predicate analysis for product code LDR, Deka Research & Development Corp.'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.

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