510(k) · Cleared
ClearedMcpulse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Co., Ltd. · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Feb 19, 2003 as substantially equivalent to K853124 (Novametrix Medical Systems, Inc., 1985) after a 145-day review. Its family tree reaches back 1 generation to 1985. 14 later devices descend from it.
- Decided
- Feb 19, 2003
- Review
- 145 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853124 (1985). 14 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK853124 Novametrix Pulse Oximeter, Model 500Novametrix Medical Systems, Inc. · 1985
- This deviceK023238 McpulseMeridian Co., Ltd. · 2003
- Descendant · cites it directly · 5 of its ownK083229 E.S Teck ( Electro Sensor Teck)Ld Technology, LLC · 2009
- Descendant · 2 generations on · 4 of its ownK102442 E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 2010
- Descendant · cites it directly · 3 of its ownK073323 SA-3000PMedicore Co., Ltd. · 2007
- Descendant · 3 generations on · 2 of its ownK160956 LD-Oxi systemLd Technology, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK083735 Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC · 2009
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K083229E.S Teck ( Electro Sensor Teck)Ld Technology, LLC · 2009 · cites it directly5descendants
- K102442E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 2010 · 2 generations on4descendants
- K073323SA-3000PMedicore Co., Ltd. · 2007 · cites it directly3descendants
- K160956LD-Oxi systemLd Technology, LLC · 2016 · 3 generations on2descendants
- K083735Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC · 2009 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853124 | Novametrix Pulse Oximeter, Model 500 | Novametrix Medical Systems, Inc. | 1985 | — |
| 0 (this device) | K023238 | Mcpulse | Meridian Co., Ltd. | 2003 | — |
| +1 | K083229 | E.S Teck ( Electro Sensor Teck) | Ld Technology, LLC | 2009 | — |
| +2 | K102442 | E.S.O. (Electro Sensor Oxi) | Ld Technology, LLC | 2010 | — |
| +1 | K073323 | SA-3000P | Medicore Co., Ltd. | 2007 | — |
| +3 | K160956 | LD-Oxi system | Ld Technology, LLC | 2016 | — |
| +2 | K083735 | Ansha Autonomic Nervous System Health Assessment Plus | Medtechs, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 JOM? 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 JOM device
- #1 K220527 PADnet Xpressscore 5.1 · 4 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 |
|---|---|---|---|
| * | K853124 | Novametrix Pulse Oximeter, Model 500Summary page 1…me: Photoelectric Plethysomograph 2. Equivalent legally marketed devices This product is similar in hnction to the Novametrix Pulse Oximeter, Model 500 5 10(k) No. : K853 124 Applicant: NOVAMETRIX MEDICAL SYSTEMS INC 3. Indications for Use (intended use) : The device provides non-invasive measuremen… | 1985 |
What descends from it? (14)
See all 146 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?
How does its category compare?
All JOM devicesJOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOM
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JOM
Too few JOM 510(k)s in any year since 2007 to give a median.
Recalls per year · JOM
No recall names JOM since 2007.
Adverse event reports per year · JOM
1in 2007
MAUDE reports naming product code JOM, 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 | 2 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device provides non-invasive measurement of pulse waveform
and heart rate by photoelectric plethysmography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023238 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023238: Mcpulse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023238
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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