Rainbow® DCI-dc3 SpCO® SpMet® SpO2 Adult Direct Connect Reusable Sensor
rainbow DCI-dc3 SpCO SpMet SpO2 Adult Direct Connect Reusable Sensor
70manufacturers in China registered for this device type
1catalogue number
77510(k) clearances naming this product code
14recalls 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 | Masimo Corporation, United States |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K080238 |
| Record published | 2016-08-23 |
| Record revised | 2025-12-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment humidity 15 to 95 % RH; Handling environment temperature -40 to 70 °C; Storage environment humidity 15 to 95 % RH; Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2201 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223721 | 2023-12-15 |
| K232389 | 2023-09-07 |
| K213676 | 2023-04-16 |
| K221953 | 2022-08-04 |
| K212876 | 2021-10-08 |
| K201770 | 2020-09-24 |
| K182887 | 2019-03-22 |
| K181956 | 2019-01-23 |
| K180046 | 2018-10-23 |
| K162675 | 2016-12-28 |
| K160940 | 2016-11-23 |
| K150314 | 2015-10-22 |
| K120984 | 2013-04-26 |
| K120657 | 2012-09-19 |
| K121914 | 2012-09-07 |
| K121912 | 2012-07-24 |
| K113596 | 2012-02-24 |
| K111403 | 2011-12-30 |
| K111621 | 2011-10-26 |
| K111888 | 2011-09-23 |
| K110028 | 2011-03-17 |
| K101031 | 2010-11-18 |
| K101896 | 2010-10-21 |
| K100428 | 2010-07-09 |
| K100403 | 2010-06-23 |
| K100617 | 2010-05-28 |
| K094046 | 2010-05-14 |
| K091241 | 2009-11-06 |
| K092838 | 2009-10-15 |
| K090662 | 2009-08-10 |
| K091057 | 2009-07-09 |
| K090165 | 2009-07-09 |
| K083622 | 2009-04-02 |
| K082052 | 2008-10-10 |
| K081659 | 2008-09-09 |
| K080238 | 2008-05-12 |
| K073024 | 2008-02-08 |
| K071024 | 2007-06-29 |
| K063140 | 2006-12-29 |
| K061204 | 2006-07-27 |
| K060143 | 2006-06-16 |
| K053477 | 2006-03-16 |
| K053269 | 2005-12-21 |
| K051439 | 2005-07-15 |
| K051212 | 2005-07-12 |
| K050252 | 2005-05-11 |
| K050068 | 2005-02-09 |
| K042536 | 2005-01-19 |
| K042346 | 2004-09-20 |
| K041815 | 2004-07-29 |
| K041204 | 2004-06-29 |
| K040259 | 2004-04-22 |
| K033998 | 2004-03-19 |
| K040214 | 2004-02-25 |
| K033296 | 2004-02-19 |
| K032551 | 2004-02-19 |
| K033349 | 2004-01-28 |
| K033298 | 2003-12-12 |
| K031330 | 2003-05-12 |
| K013792 | 2001-12-11 |
| K012992 | 2001-10-03 |
| K011851 | 2001-07-11 |
| K010419 | 2001-03-06 |
| K003167 | 2000-11-08 |
| K003244 | 2000-11-08 |
| K002939 | 2000-10-06 |
| K002751 | 2000-10-05 |
| K002682 | 2000-09-13 |
| K002477 | 2000-09-08 |
| K002574 | 2000-09-06 |
| K000126 | 2000-04-14 |
| K993555 | 1999-11-19 |
| K992238 | 1999-10-08 |
| K992340 | 1999-10-08 |
| K990966 | 1999-06-07 |
| K973887 | 1998-01-08 |
| K962603 | 1997-02-06 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Masimo Corporation | 510(k) number | 2015-10-28 | Class II | Finished device change control | These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters. | 3476 units total (3322 units in US) | 2016-05-18 |
Recalls
10 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-02-15 | Class II | Material/Component Contamination | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | 4978 units | |
| 2024-02-15 | Class II | Material/Component Contamination | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | 21,723 units | |
| 2024-02-15 | Class II | Material/Component Contamination | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | 443 units | |
| 2024-02-15 | Class II | Material/Component Contamination | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | 65 | |
| 2023-04-21 | Class II | Nonconforming Material/Component | TC-I tip clip sensor may produce readings outside the accuracy specification. | 138,926 units | |
| 2023-04-21 | Class II | Nonconforming Material/Component | TC-I tip clip sensor may produce readings outside the accuracy specification. | 123,745 units | |
| 2023-04-21 | Class II | Nonconforming Material/Component | TC-I tip clip sensor may produce readings outside the accuracy specification. | 86 units | |
| 2023-04-21 | Class II | Nonconforming Material/Component | TC-I tip clip sensor may produce readings outside the accuracy specification. | 443,799 units | |
| 2014-09-30 | Class II | Employee error | Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring dev | 21,754 units (21,222) in the U.S. and Puerto Rico) | 2016-03-28 |
| 2013-03-13 | Class II | Device Design | Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button. | 42,908 units | 2015-06-10 |
| 2010-12-23 | Not classified | Process design | Masimo Corporation is initiating a voluntary recall on the Pronto-7 rainbow 4D Resuable Sensor because when performing an SpHb measurement, the sensor may incorrectly read actual finger temperature. As a result, Pronto-7 Check Pulse CO-Oxi | 497 | 2013-03-26 |
| 2006-02-02 | Not classified | Other | Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED’s used in the calculation ofSpO2 and SpCO. The SpO2 reading m | 321 | 2008-06-17 |
| 2005-06-10 | Not classified | Other | Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm. | 8,110 | 2008-06-17 |
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.