Moor Instruments, Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Moor Instruments, Ltd.” (first 1991, latest 2016), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 | 1 | 378 |
| 2013 | 1 | 101 |
| 2014 | 1 | 201 |
| 2015 | 0 | — |
| 2016 | 1 | 232 |
| 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 |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | 8 | 8 |
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| MUD | Oximeter, Tissue Saturation | 1 | 1 |
Review panels
Most recent Moor Instruments, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152749 | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager | DPT | 2016-05-12 | 232 |
| K132163 | MOORLDLS-BI LASER DOPPLER BURNS IMAGER | DPT | 2014-01-29 | 201 |
| K122943 | MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER | DPT | 2013-01-03 | 101 |
| K112826 | NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR | MUD | 2012-10-10 | 378 |
| K102433 | MOORVMS-PRES PRESSURE CUFF CONTROLLER | DPW | 2010-11-18 | 84 |
| K083082 | MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS | GEX | 2009-01-13 | 89 |
| K060976 | MOORLD12-B1 LASER DOPPLER BURNS IMAGER | DPT | 2007-03-27 | 351 |
| K063586 | MOORFLPI FULL-FIELD LASER PERFUSION IMAGER | DPT | 2007-01-25 | 55 |
| K063561 | MOORLDLS LASER DOPPLER LINE SCANNER | DPT | 2007-01-19 | 53 |
| K032841 | MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR | DPT | 2003-12-10 | 90 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Moor Instruments, Ltd..
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 Moor Instruments, Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Moor Instruments, Ltd.” (first 1991, latest 2016), across 4 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 Moor Instruments, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Moor Instruments, Ltd. is 90 days.
Which FDA product codes appear under Moor Instruments, Ltd.?
The most frequent FDA product codes under this applicant name are DPT (Probe, Blood-Flow, Extravascular, 8); GEX (Powered Laser Surgical Instrument, 4); DPW (Flowmeter, Blood, Cardiovascular, 1).
Next steps
- See all 14 Moor Instruments, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DPT, Moor Instruments, Ltd.'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.