510(k) · Cleared

Cleared

Shenzhen Med-Link Pulse Oximeter Probe

K113727510(k) TraditionalCleared Mar 21, 2013458-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 Med-Link Electronics Tech Co., Ltd. · DQA Oximeter

Cleared on Mar 21, 2013 as substantially equivalent to K072194 (Renu Medical, Inc., 2007) after a 458-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it.

Decided: Mar 21, 2013
Review: 458 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K072194 (2007). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK072194 Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25Renu Medical, Inc. · 2007
This deviceK113727 Shenzhen Med-Link Pulse Oximeter ProbeShenzhen Med-Link Electronics Tech Co., Ltd. · 2013
Descendant · cites it directly · 0 of its ownK183277 SpO2 SensorShenzhen Upnmed Equipment Co., Ltd. · 2019

Most influential descendants

Showing 1 of 1 · See all

K183277SpO2 SensorShenzhen Upnmed Equipment Co., Ltd. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K072194	Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25	Renu Medical, Inc.	2007	—
0 (this device)	K113727	Shenzhen Med-Link Pulse Oximeter Probe	Shenzhen Med-Link Electronics Tech Co., Ltd.	2013	—
+1	K183277	SpO2 Sensor	Shenzhen Upnmed Equipment Co., Ltd.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K113727, 2007–2019Source: 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

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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
*	K072194	Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25 Summary page 1 …ion condition. Predicate Device Reprocessed NellcorM D-25 Oximetry Sensor. K Number: K072194 Manufacturer: ReNu Medical, Inc. Instrument Instrument Compatibility: N…	Renu Medical, Inc.	2007	—

Also cleared against K072194: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K183277	SpO2 Sensor	Shenzhen Upnmed Equipment Co., Ltd.	2019	0

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, K183277 (Shenzhen Upnmed Equipment Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K072194.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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?

Shenzhen Med-link disposable probe, model S0136J-L, is indicated for single patient use when continuous, non-Invasive arterial oxygen saturation and pulse rate monitoring are required for adult patients or pediatric patients weighing more than 30 kg. The S0136J-L is contraindicated for use with patients during motion condition.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113727 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113727: Shenzhen Med-Link Pulse Oximeter Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113727

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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