Fore-Sight Elite®
Fore-Sight Elite sensors measure light absorption in tissue as part of a regional tissue-oxygenation monitor. Multiple LED wavelengths from 660 to 900 nm provide the optical signals used to…
Fore-Sight Elite sensors measure light absorption in tissue as part of a regional tissue-oxygenation monitor. Multiple LED wavelengths from 660 to 900 nm provide the optical signals used to estimate hemoglobin oxygen saturation beneath the sensor.
The sensor connects through a preamplifier to the monitor, which controls the measurement sequence and processes the detected light. Sensor size determines the targeted penetration depth and the applicable patient and tissue configuration.
Listed Item
Tissue Oximeter Sensor (Non adhesive Small)
Sensor Configurations
The range includes large, medium and small sensors, with a small non-adhesive option. Adhesive and foam or fabric contact constructions provide different sensor presentations; the sensor remains the patient-contact optical component within the monitor system.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Sichuan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Cas Medical Systems, Inc., United States |
|---|---|
| FDA product code | MUD |
| Device type | Oximeter, Tissue Saturation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| 510(k) | K143675 |
| Record published | 2017-03-06 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 20, pack of 10 |
| Sizes | Length 2.5 to 5 cm; height 2.5 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-07-1103 | Length 5.0 cm | In distribution |
| 01-07-1101 | Length 2.5 cm | In distribution |
| 01-06-3014 | In distribution | |
| 01-06-1100 | In distribution | |
| 01-07-4103 | In distribution | |
| 01-06-3101 | In distribution | |
| 01-06-1001 | In distribution | |
| 01-07-1100 | Height 2.5 cm | In distribution |
| 01-06-3000 | In distribution | |
| 01-07-1102 | Length 4.0 cm | In distribution |
| 01-06-3100 | In distribution | |
| 01-06-1000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invos | Covidien LP | 54 |
| Nonin | Nonin Medical, Inc. | 30 |
| Fore-Sight® | Cas Medical Systems, Inc. | 9 |
| ForeSight | Edwards Lifesciences Technology Sarl | 7 |
| Spectros T-Stat | Spectros Corporation | 7 |
| Component Neuromonitoring System | Moberg Research, Inc. | 6 |
| HyperView | Hypermed Imaging, Inc. | 6 |
| O3 | Masimo Corporation | 5 |
| Mespere | Mespere Lifesciences Inc. | 3 |
| SnapshotNIR | Kent Imaging Inc | 2 |
| Moor Instruments Ltd | Moor Instruments Ltd. | 2 |
| T.Ox SS Sensor | Vioptix, Inc. | 1 |
Showing 12 of 30. All products under Oximeter, Tissue Saturation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190270 | 2019-10-21 |
| K180003 | 2018-05-10 |
| K143675 | 2015-04-10 |
| K133879 | 2014-04-29 |
| K123700 | 2013-04-11 |
| K112820 | 2012-01-26 |
| K094030 | 2010-12-23 |
| K091452 | 2009-08-21 |
| K061960 | 2006-09-05 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2022-03-01 | Class II | Software in the Use Environment | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and leg | 402 units |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2022-03-01 | Class II | Software in the Use Environment | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and leg | 8389 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.