# Truly Instrument Limited

- Location (FDA's records): Shanwei, CN
- FDA decisions: 10 (2008–2023): 10 510(k) clearances
- Names in FDA's records: Truly Instrument Limited (5); Truly Instrument Co., Ltd. (4); Truly Instrument , Ltd. (1)
- Product codes: DXN (8), FLL (2)
- 510(k) review time since 2016: median 209 days, against 170 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 12 (6 its own); citations of its devices by later devices: 9 (6 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
- Digibio Technology Corp.: 2 (https://510kreport.com/company/digibio-technology)
- Microlife Corp.: 2 (https://510kreport.com/company/microlife)
- Ya Horng Electronic Co., Ltd.: 1 (https://510kreport.com/company/ya-horng-electronic)
- Joytech Healthcare Co., Ltd.: 1 (https://510kreport.com/company/joytech-healthcare)

## Firms that cite its devices most
- Shenzhen Combei Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-combei-technology)
- Weony (Shenzhen) Technology Co., Ltd.: 1 (https://510kreport.com/company/weony-shenzhen-technology)
- Shenzhen Finicare Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-finicare)

## Its most-cited devices
- K091434: Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M (2009), cited by 4
- K091415: Truly  Automatic Wrist Blood Pressure Monitor, Model DW100,DW200, DW500,DW700,DW703,DW701M.702M (2009), cited by 2
- K161846: Automatic Arm Bluetooth Blood Pressure Monitor (2016), cited by 2
- K192023: Arm Blood Pressure Monitor (2019), cited by 1

## Recent decisions
- K220276: Infrared Thermometer TET-351 (Feb 17, 2023)
- K192023: Arm Blood Pressure Monitor (Dec 23, 2019)
- K170545: Automatic Wrist Bluetooth Blood Pressure Monitor (Nov 21, 2017)
- K161846: Automatic Arm Bluetooth Blood Pressure Monitor (Oct 24, 2016)
- K113083: Truly Automatic Arm Blood Pressure Monitor (Jan 19, 2012)
- K113085: Tryly Automatic Wrist Blood Pressure Monitor (Jan 12, 2012)
- K091415: Truly  Automatic Wrist Blood Pressure Monitor, Model DW100,DW200, DW500,DW700,DW703,DW701M.702M (Sep 4, 2009)
- K091434: Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M (Sep 4, 2009)

Source page: https://510kreport.com/company/truly-instrument