510(k) · Cleared
ClearedSA-3000P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicore Co., Ltd. · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Nov 29, 2007 as substantially equivalent to K023238 (Meridian Co., Ltd., 2003) after a 2-day review. Its family tree reaches back 2 generations to 1985. 3 later devices descend from it.
- Decided
- Nov 29, 2007
- Review
- 2 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K853124 (1985). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK853124 Novametrix Pulse Oximeter, Model 500Novametrix Medical Systems, Inc. · 1985
- 1 generation backK023238 McpulseMeridian Co., Ltd. · 2003
- This deviceK073323 SA-3000PMedicore Co., Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK083735 Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC · 2009
- Descendant · 2 generations on · 1 of its ownK101983 Critical Care AssessmentCritical Patient Care, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK191266 VitalScan ANSMedeia, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853124 | Novametrix Pulse Oximeter, Model 500 | Novametrix Medical Systems, Inc. | 1985 | — |
| −1 | K023238 | Mcpulse | Meridian Co., Ltd. | 2003 | — |
| 0 (this device) | K073323 | SA-3000P | Medicore Co., Ltd. | 2007 | — |
| +1 | K083735 | Ansha Autonomic Nervous System Health Assessment Plus | Medtechs, LLC | 2009 | — |
| +2 | K101983 | Critical Care Assessment | Critical Patient Care, Inc. | 2010 | — |
| +2 | K191266 | VitalScan ANS | Medeia, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K023238 | McpulseSummary page 1…to the indication for Use and the technological characteristics of the predicate device, the Meridian McPulse device (K023238) 028 p S… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083735 | Ansha Autonomic Nervous System Health Assessment Plus | 2009 | 2 |
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 22 years and passes through 3 companies; a new generation was cleared every 17.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K083735 (Medtechs, LLC, 2009) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K023238.
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. 2007, this device’s year, is highlighted.
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 noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073323 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073323: SA-3000P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073323
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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