510(k) · Cleared
ClearedNovametrix Pulse Oximeter, Model 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novametrix Medical Systems, Inc. · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Nov 6, 1985 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Nov 6, 1985
- Review
- 104 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK853124 Novametrix Pulse Oximeter, Model 500Novametrix Medical Systems, Inc. · 1985
- Descendant · cites it directly · 14 of its ownK023238 McpulseMeridian Co., Ltd. · 2003
- Descendant · 2 generations on · 5 of its ownK083229 E.S Teck ( Electro Sensor Teck)Ld Technology, LLC · 2009
- Descendant · 3 generations on · 4 of its ownK102442 E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 2010
- Descendant · 2 generations on · 3 of its ownK073323 SA-3000PMedicore Co., Ltd. · 2007
- Descendant · 4 generations on · 2 of its ownK160956 LD-Oxi systemLd Technology, LLC · 2016
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K023238McpulseMeridian Co., Ltd. · 2003 · cites it directly14descendants
- K083229E.S Teck ( Electro Sensor Teck)Ld Technology, LLC · 2009 · 2 generations on5descendants
- K102442E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 2010 · 3 generations on4descendants
- K073323SA-3000PMedicore Co., Ltd. · 2007 · 2 generations on3descendants
- K160956LD-Oxi systemLd Technology, LLC · 2016 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853124 | Novametrix Pulse Oximeter, Model 500 | Novametrix Medical Systems, Inc. | 1985 | — |
| +1 | K023238 | Mcpulse | Meridian Co., Ltd. | 2003 | — |
| +2 | K083229 | E.S Teck ( Electro Sensor Teck) | Ld Technology, LLC | 2009 | — |
| +3 | K102442 | E.S.O. (Electro Sensor Oxi) | Ld Technology, LLC | 2010 | — |
| +2 | K073323 | SA-3000P | Medicore Co., Ltd. | 2007 | — |
| +4 | K160956 | LD-Oxi system | Ld Technology, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 163 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?
- Of its descendants, K023238 (Meridian Co., Ltd., 2003) has gone furthest, with 14 descendants of its own.
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 | — |
https://510kreport.com/device/K853124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K853124: Novametrix Pulse Oximeter, Model 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K853124
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026