Capsule Vitals Plus
Vitals Plus Backpack Oximeter Masimo Thermometer Exergen Capno Masimo
70manufacturers in China registered for this device type
2catalogue numbers in this listing
30recalls on this code
Who Else Makes It
Concentrated in Guangdong (46), Jiangsu (7), Beijing (5). 10 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 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Beijing Kingst Commercial & Trade Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Showing 12 of 70. All 70 manufacturers in China registered for Oximeter
Record
| Listed by | Philips North America LLC, United States |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K210204 |
| Record published | 2025-07-31 |
| Record revised | 2023-08-14 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CAP-VP-NIBPAH-MON-HW | In distribution | |
| CAP-VP-NIBPAH-MON-HW | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 2,838 |
| APK | APK Technology Co., Ltd. | 2,678 |
| ChoiceMMed | Beijing Choice Electronic Technology Co., Ltd. | 151 |
| Nellcor | Covidien LP | 138 |
| Nonin | Nonin Medical, Inc. | 129 |
| Orantech | Orantech Inc. | 97 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 93 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Medichoice | Owens & Minor Distribution, Inc. | 62 |
| Caremed | Shenzhen Caremed Medical Technology Co., Ltd. | 55 |
| Sensoronics | Sensoronics Incorporated | 53 |
| Virtuox | Healthcare Logistics Systems | 36 |
Showing 12 of 1,063. All products under Oximeter
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 1,329 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 40 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 24 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 1 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 178 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 538 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 1,195 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 1,848 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 45 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 1,112 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 42 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 34 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 38 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 5 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 144 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 44 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 676 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 1,368 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 538 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 0 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 48 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 38 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 359 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 233 | 2016-12-08 |
| 2009-11-19 | Not classified | Nonconforming Material/Component | Power cords’ prongs may crack or fail — Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord’s prongs may c | 14 | 2016-12-08 |
| 2008-09-11 | Not classified | Software design | Multiprint report may contain incorrect vital data for patients | 52 units | 2017-02-06 |
| 2008-07-22 | Not classified | Software design | Software: If Weight Limits edited, values will return to default values that were deleted | 49 units | 2012-05-16 |
| 2006-09-21 | Not classified | Other | Unexpected pulse oximetry (Sp02) readings (100%) over time when a sensor is not attached to the patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM | 69696 units | 2020-08-11 |
| 2006-09-21 | Not classified | Other | Unexpected pulse oximetry (Sp02) readings (100%) over time when sensor is not attached to patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM | 442 units | 2020-08-11 |
| 2006-07-24 | Not classified | Other | Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached | 48,699 units | 2020-08-11 |
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.