# Deka Research and Development

- Location (FDA's records): Manchester, NH
- FDA decisions: 16 (2015–2026): 16 510(k) clearances
- Names in FDA's records: Deka Research and Development (13); Deka Research and Development Corp. (2); Deka Research and Development Corporation (1)
- Product codes: QFG (4), QJI (2), LDR (2), QJY (2), FPA (2), KPO (1), KDI (1), FKX (1), FRN (1)
- 510(k) review time since 2016: median 89 days, against 150 for FDA's reviews in the same codes and years (5 of 11 faster)
- Predicates its devices cite: 20 (5 its own); citations of its devices by later devices: 8 (5 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Deka Research & Development Corp.: 5 (https://510kreport.com/company/deka-research-development)
- Tidepool Project: 1 (https://510kreport.com/company/tidepool-project)
- Zyno Medical, LLC: 1 (https://510kreport.com/company/zyno-medical)
- Gambro Renal Products: 1 (https://510kreport.com/company/gambro-renal-products)
- Tandem Diabetes Care, Inc.: 1 (https://510kreport.com/company/tandem-diabetes-care)
- Aksys, Ltd.: 1 (https://510kreport.com/company/aksys)
- Nephros, Inc.: 1 (https://510kreport.com/company/nephros)
- Nxstage Medical, Inc.: 1 (https://510kreport.com/company/nxstage-medical)

## Firms that cite its devices most
- Deka Research & Development Corp.: 2 (https://510kreport.com/company/deka-research-development)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)

## Its most-cited devices
- K233952: DEKA ACE Pump System (2024), cited by 2
- K232316: DEKA Infusion System, DEKA Administration Set (2024), cited by 1
- K202690: Remunity Pump for Remodulin (treprostinil) Injection (2020), cited by 1
- K213536: DEKA ACE Pump System (2023), cited by 1
- K151525: Amia Automated PD System with Sharesource (2015), cited by 1
- K241736: Remunity 2.0 Pump for Remodulin (treprostinil) Injection (2025), cited by 1

## Recent decisions
- K262576: twiist Loop Algorithm (Oct 15, 2026)
- K261672: twiist Automated Insulin Delivery (AID) System (Jun 17, 2026)
- K261530: iiSure Infusion Set (Jun 3, 2026)
- K243841: Sparta Infusion Set for Insulin (Aug 1, 2025)
- K241736: Remunity 2.0 Pump for Remodulin (treprostinil) Injection (Jan 16, 2025)
- K242693: DEKA Infusion System, DEKA Administration Set (Oct 7, 2024)
- K240920: HemoCare Bicarbonate Concentrate Set (BCS) (Jul 12, 2024)
- K233557: HemoCare Hemodialysis System (Jul 12, 2024)

Source page: https://510kreport.com/company/deka-research-and-development