FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
twiist system
K Number: K250930
·
Decision Apr 2, 2025
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
10
Review Days
5
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- twiist system
- K Number
- K250930
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5730
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deka Research & Development Corp.
- Date Received
- March 28, 2025
- Decision Date
- April 2, 2025
- Product Code
- QFG
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QFG), ordered by most recent decision date.
twiist Automated Insulin Delivery (AID) System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iLet ACE Pump
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MiniMed Flex pump
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tandem Mobi insulin pump with interoperable technology
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iLet ACE Pump
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Deka Research & Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) Injection | Mar 11, 2025 | Substantially Equivalent |
| K243354 | Remunity System | Nov 27, 2024 | Substantially Equivalent |
| K172601 | Next Generation iBOT | Mar 2, 2018 | Substantially Equivalent |
| K124018 | AMIA AUTOMATED PD SYSTEM | Jun 14, 2013 | Substantially Equivalent |
| K093915 | DEKA TAC DEVICE | Aug 23, 2011 | Substantially Equivalent |
| K103220 | VOYAGER PERITONEAL DIALYSIS SYSTEM | Jul 29, 2011 | Substantially Equivalent |
| K863204 | DEKA JR. | Sep 3, 1986 | Substantially Equivalent |
| K843254 | DK*300 VOLUMETRIC INFUSION CONTROLLER | Oct 11, 1984 | Substantially Equivalent |
| K843054 | DEKA SOLUTION ADMIN. SET DK 302-A | Sep 13, 1984 | Substantially Equivalent |