Larsen & Toubro Limited: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Larsen & Toubro Limited” (first 2003, latest 2011), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 57 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 15 | 15 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Review panels
- Cardiovascular (17)
- Radiology (1)
Most recent Larsen & Toubro Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103686 | STAR 50 N | MWI | 2011-03-15 | 88 |
| K103763 | STELLAR 300 | MWI | 2011-03-11 | 78 |
| K093017 | STELLAR 300 | MWI | 2010-04-29 | 212 |
| K092153 | SKYLINE 55, MODEL VER 1 | MWI | 2009-11-20 | 127 |
| K090443 | PLANET 55, MODEL 100 | MHX | 2009-06-05 | 105 |
| K090172 | STAR 55 MODEL 100 | MHX | 2009-06-05 | 133 |
| K082685 | GALAXY 55 | MWI | 2008-09-26 | 11 |
| K081552 | SKYLINE 55 | MWI | 2008-07-31 | 58 |
| K080173 | STAR 55 | MWI | 2008-02-08 | 15 |
| K071472 | PLANET 55 | MWI | 2007-09-21 | 115 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Larsen & Toubro 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Larsen & Toubro Limited?
FDA lists 18 510(k) clearances under the applicant name “Larsen & Toubro Limited” (first 2003, latest 2011), across 3 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 Larsen & Toubro Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Larsen & Toubro Limited is 57 days.
Which FDA product codes appear under Larsen & Toubro Limited?
The most frequent FDA product codes under this applicant name are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 15); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 2); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1).
Next steps
- See all 18 Larsen & Toubro Limited clearances with predicates and recalls
- Run predicate analysis for product code MWI, Larsen & Toubro 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, 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.