510(k) · Cleared
ClearedPC-60, Non-Invasivepulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Creative Industry Co., Ltd. · DQA Oximeter
Cleared on Jul 13, 2007 as substantially equivalent to K051107 (Nonin Medical, Inc., 2005) after a 218-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Jul 13, 2007
- Review
- 218 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001085 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
- 1 generation backK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
- This deviceK063641 PC-60, Non-Invasivepulse OximeterShenzhen Creative Industry Co., Ltd. · 2007
- Descendant · cites it directly · 1 of its ownK120502 PC-60NW Fingertip OximeterShenzhen Creative Industry Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK150093 Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5…Shenzhen Creative Industry Co., Ltd. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | Nonin Medical, Inc. | 2000 | — |
| −1 | K051107 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2005 | — |
| 0 (this device) | K063641 | PC-60, Non-Invasivepulse Oximeter | Shenzhen Creative Industry Co., Ltd. | 2007 | — |
| +1 | K120502 | PC-60NW Fingertip Oximeter | Shenzhen Creative Industry Co., Ltd. | 2012 | — |
| +1 | K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D… | Shenzhen Creative Industry Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K051107 | Onyx II Finger Pulse Oximeter, Model 9550Summary page 1…vice for Non-invasive pulse oximeter, Model PC-60 Fingertip Oximeter is: Nonin OnyxClI Fingertip Oximeter, pulse oximeter, Model 9550, cleared by FDA through 5 10(k) No. K051 107. Device Description The Shenzhen Creative Industry Co., LTD, Model PC-60 Fingertip oximeter is to monitor pulse rate and SPO2, f… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K120502 (Shenzhen Creative Industry Co., Ltd., 2012) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K051107.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 PC-60 Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries, it is small in size, convenient to use, and easy to carry. This device is applicable for spot-checking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device is 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/K063641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063641: PC-60, Non-Invasivepulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063641
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