Ld Technology, LLC: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Ld Technology, LLC” (first 2009, latest 2020), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 95 days. Since 2017 the median was 97 days, against 184 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 | 1 | 119 |
| 2013 | 2 | 60 |
| 2014 | 1 | 93 |
| 2015 | 2 | 154 |
| 2016 | 1 | 92 |
| 2017 | 1 | 18 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 98 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ld Technology, LLC took a median 97 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 184 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 4 | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| GZO | Device, Galvanic Skin Response Measurement | 3 | 3 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| MNW | Analyzer, Body Composition | 1 | 1 |
Review panels
Most recent Ld Technology, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200287 | BP-BT Kiosk | DXN | 2020-05-15 | 100 |
| K200141 | Oxi-W System | MWI | 2020-04-27 | 97 |
| K173696 | TBL-ABI System | JOM | 2017-12-19 | 18 |
| K160956 | LD-Oxi system | MWI | 2016-07-06 | 92 |
| K152216 | SudoC | GZO | 2015-09-24 | 48 |
| K143152 | TM-ABI system | JOM | 2015-07-22 | 261 |
| K140412 | ANS1 SOFTWARE | DXN | 2014-05-22 | 93 |
| K131568 | SUDO PATH | GZO | 2013-06-28 | 29 |
| K130056 | PATIENT MONITOR | MWI | 2013-04-11 | 92 |
| K113264 | ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) | DXN | 2012-03-02 | 119 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ld Technology, LLC.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ld Technology, LLC?
FDA lists 14 510(k) clearances under the applicant name “Ld Technology, LLC” (first 2009, latest 2020), across 6 product codes in 4 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 Ld Technology, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ld Technology, LLC is 95 days. Since 2017: 97 days, versus 184 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ld Technology, LLC?
The most frequent FDA product codes under this applicant name are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 4); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3); GZO (Device, Galvanic Skin Response Measurement, 3).
Next steps
- See all 14 Ld Technology, LLC clearances with predicates and recalls
- Run predicate analysis for product code MWI, Ld Technology, LLC'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.