510(k) · Cleared
ClearedVital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Creative Industry Co., Ltd. · DQA Oximeter
Cleared on Mar 30, 2010 as substantially equivalent to K060065 (Oridion Capnography, Inc., 2006) and 1 other predicate after a 182-day review. Its family tree reaches back 10 generations to 1997. 1 of the 57 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it.
- Decided
- Mar 30, 2010
- Review
- 182 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K962603 (1997). 40 ancestors in all, the oldest K893221 (1990). 16 later devices descend from it, 2 citing it directly. 1 of the 57 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations between
- 3 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 2 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 1 generation backK083821 Vital Signs MonitorEdan Instruments, Inc. · 2009
- This deviceK093016 Vital Signs MonitorShenzhen Creative Industry Co., Ltd. · 2010
- Descendant · cites it directly · 13 of its ownK123711 Patient MonitorShenzhen Creative Industry Co., Ltd. · 2013
- Descendant · 2 generations on · 6 of its ownK170047 All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd. · 2017
- Descendant · 3 generations on · 4 of its ownK210086 Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK172792 Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd. · 2018
- Descendant · 3 generations on · 2 of its ownK201468 Pulse OximeterShenzhen Creative Industry Co., Ltd. · 2021
Show all 10 generations
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 8 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 7 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 6 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 5 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 4 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 2 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 1 generation backK083821 Vital Signs MonitorEdan Instruments, Inc. · 2009
- This deviceK093016 Vital Signs MonitorShenzhen Creative Industry Co., Ltd. · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K970209 Capnocheck Plus4 generations back · 1997
Most influential descendants
Showing 5 of 16 · See all- K123711Patient MonitorShenzhen Creative Industry Co., Ltd. · 2013 · cites it directly13descendants
- K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd. · 2017 · 2 generations on6descendants
- K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021 · 3 generations on4descendants
- K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd. · 2018 · 2 generations on3descendants
- K201468Pulse OximeterShenzhen Creative Industry Co., Ltd. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −9 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −8 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −7 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −6 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −5 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −4 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −3 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −2 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −1 | K083821 | Vital Signs Monitor | Edan Instruments, Inc. | 2009 | — |
| 0 (this device) | K093016 | Vital Signs Monitor | Shenzhen Creative Industry Co., Ltd. | 2010 | — |
| +1 | K123711 | Patient Monitor | Shenzhen Creative Industry Co., Ltd. | 2013 | — |
| +2 | K170047 | All-in-One Health Monitor, PC-303 | Shenzhen Creative Industry Co., Ltd. | 2017 | — |
| +3 | K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | 2021 | — |
| +2 | K172792 | Handheld Pulse Oximeter, Model SP-20 | Shenzhen Creative Industry Co., Ltd. | 2018 | — |
| +3 | K201468 | Pulse Oximeter | Shenzhen Creative Industry Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorSummary page 1…Predicate Devices: Predicate Model Manufacturer K Number Submitted Device 20 Oridion Capnostream K060065 ~Vital Signs Monitor, Model 20 riclionK060065 Capnostrarn… | 2006 |
| * | K083821 | Vital Signs MonitorSummary page 1…Capnostrarn PC-900A Capnography, Incorporated Vital Signs Eclan K(083821 Vita Signs M~onitor, Model PC-900A M… | 2009 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 10 of the 40 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K123711 (Shenzhen Creative Industry Co., Ltd., 2013) has gone furthest, with 13 descendants of its own.
- 6 other devices also cite its predicate K060065.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SP02), pulse rate, C02 and respiration rate.
The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital, environment. It is intended to be used only under regular supervision of clinical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093016 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093016: Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093016
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026