Truly Instrument Limited: FDA filings under this applicant name
FDA lists 10 510(k) clearances under 3 spellings of the applicant name “Truly Instrument Limited” (first 2008, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 114 days. Since 2017 the median was 270 days, against 182 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 90 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 111 |
| 2017 | 1 | 270 |
| 2018 | 0 | — |
| 2019 | 1 | 147 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 382 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Truly Instrument Limited took a median 270 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 8 | 8 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
Review panels
- Cardiovascular (8)
- General Hospital (2)
Most recent Truly Instrument Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220276 | Infrared Thermometer TET-351 | FLL | 2023-02-17 | 382 |
| K192023 | Arm Blood Pressure Monitor | DXN | 2019-12-23 | 147 |
| K170545 | Automatic Wrist Bluetooth Blood Pressure Monitor | DXN | 2017-11-21 | 270 |
| K161846 | Automatic Arm Bluetooth Blood Pressure Monitor | DXN | 2016-10-24 | 111 |
| K113083 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR | DXN | 2012-01-19 | 93 |
| K113085 | TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR | DXN | 2012-01-12 | 86 |
| K091434 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M | DXN | 2009-09-04 | 114 |
| K091415 | TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M | DXN | 2009-09-04 | 114 |
| K090564 | TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 | FLL | 2009-06-24 | 114 |
| K081852 | TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 | DXN | 2008-12-12 | 165 |
Recalls
openFDA lists no recalls under a recalling firm named Truly Instrument Limited.
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.
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Truly Instrument Limited (5)
- Truly Instrument Co., Ltd. (4)
- Truly Instrument , Ltd. (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Truly Instrument Limited?
FDA lists 10 510(k) clearances under 3 spellings of the applicant name “Truly Instrument Limited” (first 2008, latest 2023), across 2 product codes in 2 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 Truly Instrument Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Truly Instrument Limited is 114 days. Since 2017: 270 days, versus 182 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Truly Instrument Limited?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 8); FLL (Continuous Measurement Thermometer, 2).
Next steps
- See all 10 Truly Instrument Limited clearances with predicates and recalls
- Run predicate analysis for product code DXN, Truly Instrument Limited'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.