510(k) · Cleared
ClearedMD300C318 Fingertip Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Choice Electronic Technololgy Co., Ltd. · DQA Oximeter
Cleared on Dec 4, 2009 as substantially equivalent to K081285 (Nonin Medical, Inc., 2008) after a 100-day review. Its family tree reaches back 8 generations to 1991. 10 later devices descend from it.
- Decided
- Dec 4, 2009
- Review
- 100 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K910772 (1991). 18 ancestors in all, the oldest K893221 (1990). 10 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 7 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 3 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 2 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 1 generation backK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008
- This deviceK092620 MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009
- Descendant · cites it directly · 8 of its ownK142888 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2015
- Descendant · 2 generations on · 6 of its ownK181503 Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK230172 Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK250837 Pulse OximeterShanghai Berry Electronic Tech Co., Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK243049 Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2015 · cites it directly8descendants
- K181503Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2018 · 2 generations on6descendants
- K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2023 · 3 generations on1descendant
- K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd. · 2025 · 3 generations on0descendants
- K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −7 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −3 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −2 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −1 | K081285 | Finger Pulse Oximeter, Model 9560 | Nonin Medical, Inc. | 2008 | — |
| 0 (this device) | K092620 | MD300C318 Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2009 | — |
| +1 | K142888 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2015 | — |
| +2 | K181503 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2018 | — |
| +3 | K230172 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023 | — |
| +3 | K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2025 | — |
| +4 | K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K081285 | Finger Pulse Oximeter, Model 9560Summary page 1…mmon Name: Pulse Oximeter * Classification: 2ICFR 870.2700 Oximeter Class: I 3. Legally Marketed Predicate Device Finger Pulse Oximeter model 9560 K-number: K08 1285 NONIN MEDICAL, INC. Premarket Notification 510(k) Submission-5 I O(k) Summary Report No.: Report No.: TE20090… | 2008 |
What descends from it? (10)
2 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 18 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K142888 (Beijing Choice Electronic Technololgy Co., Ltd., 2015) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K081285.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 MD300C318 Fingertip Pulse Oximeter is intended for continuous use or spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals and home care. It is intended for adult and pediatric patients on finger between 0.3-1.0 inch (0.8 -2.5 cm) thick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092620 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092620: MD300C318 Fingertip Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092620
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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