510(k) · Cleared
ClearedPulse Oximeter, Model PM-50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DQA Oximeter
Cleared on Sep 5, 2006 as substantially equivalent to K052693 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2006) after a 104-day review. Its family tree reaches back 2 generations to 2000. 8 later devices descend from it.
- Decided
- Sep 5, 2006
- Review
- 104 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001688 (2000). 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001688 Datex-Ohmeda Tuffsat 3000 Pulse OximeterDatex-Ohmeda, Inc. · 2000
- 1 generation backK052693 PM-50 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- This deviceK061442 Pulse Oximeter, Model PM-50Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · cites it directly · 7 of its ownK072235 PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK132037 Vital Signs MonitorMindray North America · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK132038 Accutorr 7 Vital Signs MonitorMindray North America · 2014
- Descendant · 3 generations on · 1 of its ownK202892 Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK170712 Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072235PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · cites it directly7descendants
- K132037Vital Signs MonitorMindray North America · 2014 · 2 generations on3descendants
- K132038Accutorr 7 Vital Signs MonitorMindray North America · 2014 · 2 generations on2descendants
- K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc. · 2021 · 3 generations on1descendant
- K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001688 | Datex-Ohmeda Tuffsat 3000 Pulse Oximeter | Datex-Ohmeda, Inc. | 2000 | — |
| −1 | K052693 | PM-50 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| 0 (this device) | K061442 | Pulse Oximeter, Model PM-50 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +1 | K072235 | PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | 2 |
| +2 | K132037 | Vital Signs Monitor | Mindray North America | 2014 | 2 |
| +2 | K132038 | Accutorr 7 Vital Signs Monitor | Mindray North America | 2014 | — |
| +3 | K202892 | Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2021 | 1 |
| +3 | K170712 | Accutorr 7/VS-900 Vital Signs Monitor | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K052693 | PM-50 Pulse OximeterSummary page 1…imeter, Pulse Class I[ Legally Marketed Predicate Device: 0026 K052693 PM-50 Pulse Oximeter MINDRAYrPROPRIETARY Page 1 of 3… | 2006 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072235 | PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor | 2007 | 7 |
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 6 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072235 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2007) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K052693.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 disposable and reusable sensors labeled for patients ranging from neonates to adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061442: Pulse Oximeter, Model PM-50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061442
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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