510(k) · Cleared

Cleared

Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1

K150093510(k) SpecialCleared Jun 3, 2015138-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 Creative Industry Co., Ltd. · DQA Oximeter

Cleared on Jun 3, 2015 as substantially equivalent to K063641 (Shenzhen Creative Industry Co., Ltd., 2007) and 1 other predicate after a 138-day review. Its family tree reaches back 4 generations to 2000.

Decided: Jun 3, 2015
Review: 138 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K001085 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
3 generations backK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
2 generations backK063641 PC-60, Non-Invasivepulse OximeterShenzhen Creative Industry Co., Ltd. · 2007
1 generation backK120502 PC-60NW Fingertip OximeterShenzhen Creative Industry Co., Ltd. · 2012
This deviceK150093 Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5…Shenzhen Creative Industry Co., Ltd. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K001085	Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500	Nonin Medical, Inc.	2000	—
−3	K051107	Onyx II Finger Pulse Oximeter, Model 9550	Nonin Medical, Inc.	2005	—
−2	K063641	PC-60, Non-Invasivepulse Oximeter	Shenzhen Creative Industry Co., Ltd.	2007	—
−1	K120502	PC-60NW Fingertip Oximeter	Shenzhen Creative Industry Co., Ltd.	2012	—
0 (this device)	K150093	Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D…	Shenzhen Creative Industry Co., Ltd.	2015	—

FIG. 1 — Lineage of K150093, 2000–2015Source: 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? (2)

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
*	K063641	PC-60, Non-Invasivepulse Oximeter Summary page 5 …Oximeter 14 3. Predicate Devices : Shenzhen Creative Industry Co., Ltd, PC-60 Fingertip Oximeter K063641and PC 60 NW Fingertip Oximeter K120502. This submission is a Special 510(k) submission, based upon standards and t…	Shenzhen Creative Industry Co., Ltd.	2007	—
*	K120502	PC-60NW Fingertip Oximeter Summary page 5 …14 3. Predicate Devices : Shenzhen Creative Industry Co., Ltd, PC-60 Fingertip Oximeter K063641and PC 60 NW Fingertip Oximeter K120502. This submission is a Special 510(k) submission, based upon standards and the predicate is simply the original bas…	Shenzhen Creative Industry Co., Ltd.	2012	—

Also cleared against K063641: 1 other device →

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 15 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K063641.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?

The Pulse OximeterV are intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display.

These devices are used for spot-checking a patient's SpO2 and pulse rate in a home or clinical environment. They are intended to be used by adult and pediatric patients. These devices are recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150093 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150093: Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150093

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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