510(k) · Cleared
ClearedPulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hunan Accurate Bio-Medical Technology Co., Ltd. · DQA Oximeter
Cleared on Jan 2, 2025 as substantially equivalent to K230172 (Beijing Choice Electronic Technology Co., Ltd., 2023) after a 97-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- Jan 2, 2025
- Review
- 97 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K910772 (1991). 22 ancestors in all, the oldest K893221 (1990). No later device cites it as a predicate yet.
- Root · 12 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 8 generations between
- 3 generations backK142888 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2015
- 2 generations backK181503 Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2018
- 1 generation backK230172 Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2023
- This deviceK243049 Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2025
Show all 12 generations
- Root · 12 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 11 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 10 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 9 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 8 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 7 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 6 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 5 generations backK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008
- 4 generations backK092620 MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009
- 3 generations backK142888 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2015
- 2 generations backK181503 Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2018
- 1 generation backK230172 Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. · 2023
- This deviceK243049 Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −11 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −10 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −9 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −8 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −7 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −6 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −5 | K081285 | Finger Pulse Oximeter, Model 9560 | Nonin Medical, Inc. | 2008 | — |
| −4 | K092620 | MD300C318 Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2009 | — |
| −3 | K142888 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2015 | — |
| −2 | K181503 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2018 | — |
| −1 | K230172 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K230172 | Pulse OximeterSummary page 5…Traditional 510(K) 4. Predicate Device Manufacturer: Beijing Choice Electronic Technology Co., Ltd. Device name: Pulse Oximeter, Model: MD300C19 510(K) Number: K230172 5. Device Description The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the m… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 22 ancestors have a recall of any class.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using. The Pulse Oximeter FS20C and…
Read the full statement (127 words)
The Pulse Oximeter FS20P is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adolescent, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
The Pulse Oximeter FS20C and FS10C is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult patients in hospitals, hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243049: Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243049
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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