510(k) · Cleared

Cleared

PM-50 Pulse Oximeter

K052693510(k) TraditionalCleared Mar 30, 2006183-day reviewClass II21 CFR 870.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DQA Oximeter

Cleared on Mar 30, 2006 as substantially equivalent to K001688 (Datex-Ohmeda, Inc., 2000) after a 183-day review. Its family tree reaches back 1 generation to 2000. 13 later devices descend from it.

Decided: Mar 30, 2006
Review: 183 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001688 (2000). 13 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK001688 Datex-Ohmeda Tuffsat 3000 Pulse OximeterDatex-Ohmeda, Inc. · 2000
This deviceK052693 PM-50 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
Descendant · cites it directly · 8 of its ownK061442 Pulse Oximeter, Model PM-50Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
Descendant · 2 generations on · 7 of its ownK072235 PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · Recalled
Descendant · cites it directly · 3 of its ownK172792 Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd. · 2018
Descendant · 3 generations on · 3 of its ownK132037 Vital Signs MonitorMindray North America · 2014 · Recalled
Descendant · 2 generations on · 2 of its ownK201468 Pulse OximeterShenzhen Creative Industry Co., Ltd. · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2006high 2 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 13 · See all

K061442Pulse Oximeter, Model PM-50Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · cites it directly8descendants
K072235PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 2 generations on7descendants
K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd. · 2018 · cites it directly3descendants
K132037Vital Signs MonitorMindray North America · 2014 · 3 generations on3descendants
K201468Pulse OximeterShenzhen Creative Industry Co., Ltd. · 2021 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001688	Datex-Ohmeda Tuffsat 3000 Pulse Oximeter	Datex-Ohmeda, Inc.	2000	—
0 (this device)	K052693	PM-50 Pulse Oximeter	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2006	—
+1	K061442	Pulse Oximeter, Model PM-50	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2006	—
+2	K072235	PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2007	2
+1	K172792	Handheld Pulse Oximeter, Model SP-20	Shenzhen Creative Industry Co., Ltd.	2018	—
+3	K132037	Vital Signs Monitor	Mindray North America	2014	2
+2	K201468	Pulse Oximeter	Shenzhen Creative Industry Co., Ltd.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2014	2	0
2017	1	0
2018	1	0
2019	1	0
2021	2	0
2022	2	0
2023	1	0
2024	1	0

FIG. 1 — Lineage of K052693, 2000–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K001688	Datex-Ohmeda Tuffsat 3000 Pulse Oximeter Summary page 1 …Class I[ 21 CFR 870.2710 Ear Oximeter, Pulse Class II Legally Marketed Predicate Device: K001688 Datex-Ohmeda TuffSat 3000 Pulse Oximeter(by Datex-Ohmeda Inc.) MINDRAY'PROPRIETARY…	Datex-Ohmeda, Inc.	2000	—

Also cleared against K001688: 1 other device →

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061442	Pulse Oximeter, Model PM-50	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2006	8
K172792	Handheld Pulse Oximeter, Model SP-20	Shenzhen Creative Industry Co., Ltd.	2018	3

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?

Its one ancestor has no recall.
Of its descendants, K061442 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2006) has gone furthest, with 8 descendants of its own.
1 other device also cites its predicate K001688.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007high 2,082 (2015) · low 164 (2011)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 sensors labeled for patients ranging from neonates to adults.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052693 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052693: PM-50 Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052693

Report an extraction error

Are you the manufacturer?

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