# Chirana T. Injecta

- Location (FDA's records): Stará Turá, SK
- FDA decisions: 6 (2021–2026): 6 510(k) clearances
- Names in FDA's records: Chirana T. Injecta (4); Chirana T.Injecta,A.S. (2)
- Product codes: FMF (3), JKA (1), FMI (1), PNR (1)
- 510(k) review time since 2016: median 269 days, against 211 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shanghai Kohope Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/shanghai-kohope-medical-devices)
- Berpu Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/berpu-medical-technology)
- Sol-Millennium Medical, Inc.: 1 (https://510kreport.com/company/sol-millennium-medical)
- Ultimed, Inc.: 1 (https://510kreport.com/company/ultimed)
- Jiangsu Kangbao Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-kangbao-medical-equipment)

## Its most-cited devices
- K201044: CHIRANA Insulin Syringes (2022), cited by 1

## Recent decisions
- K252483: Enteral Syringe (20ml, 60ml) (Jul 1, 2026)
- K252279: Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (Apr 17, 2026)
- K242434: Insulin Syringes (Dec 24, 2024)
- K220614: MEDOJECT fine Pen Needles (Jun 15, 2022)
- K201044: CHIRANA Insulin Syringes (Jan 18, 2022)
- K201009: CHIRAVAC Blood Collection Needles (Jul 21, 2021)

Source page: https://510kreport.com/company/chirana-t-injecta