510(k) · Cleared
ClearedFingertip Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Choice Electronic Technology Co., Ltd. · DQA Oximeter
Cleared on Oct 11, 2018 as substantially equivalent to K142888 (Beijing Choice Electronic Technololgy Co., Ltd., 2015) after a 126-day review. Its family tree reaches back 10 generations to 1991. 6 later devices descend from it.
- Decided
- Oct 11, 2018
- Review
- 126 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K910772 (1991). 20 ancestors in all, the oldest K893221 (1990). 6 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations between
- 3 generations backK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008
- 2 generations backK092620 MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009
- 1 generation backK142888 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2015
- This deviceK181503 Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK230172 Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK250837 Pulse OximeterShanghai Berry Electronic Tech Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243049 Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK232975 Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK220101 Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 9 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 8 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 5 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 4 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 3 generations backK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008
- 2 generations backK092620 MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009
- 1 generation backK142888 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2015
- This deviceK181503 Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2023 · cites it directly1descendant
- K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd. · 2025 · cites it directly0descendants
- K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K232975Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd. · 2024 · cites it directly0descendants
- K220101Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −9 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −8 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −5 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −4 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −3 | K081285 | Finger Pulse Oximeter, Model 9560 | Nonin Medical, Inc. | 2008 | — |
| −2 | K092620 | MD300C318 Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2009 | — |
| −1 | K142888 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2015 | — |
| 0 (this device) | K181503 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2018 | — |
| +1 | K230172 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023 | — |
| +1 | K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2025 | — |
| +2 | K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2025 | — |
| +1 | K232975 | Pulse Oximeter (MD300C228) | Beijing Choice Electronic Technology Co., Ltd. | 2024 | — |
| +1 | K220101 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
Planning a device in DQA? 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? (1)
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 |
|---|---|---|---|
| * | K142888 | Fingertip Pulse OximeterSummary page 5…K181503 Page 2 of 11 Premarket Notification 510(k) Submission—Section III 510(k) Summary 3.3 Predicate Device 510(k) Number: K142888 Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C318T2 Classification Name: Oxime… | 2015 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K230172 (Beijing Choice Electronic Technology Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K142888.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Fingertip Pulse Oximeter MD300CI218 is a handheld non-invasive device intended for
spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent,
child and infant patients in hospitals, hospital-type facilities and homecare environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181503 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181503: Fingertip Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181503
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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