510(k) · Cleared
ClearedOhmniscan NG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Christine Valmy, Inc. · MNW Analyzer, Body Composition
Cleared on Aug 22, 2008 as substantially equivalent to K002835 (Bodystat, Ltd., 2001) after a 268-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Aug 22, 2008
- Review
- 268 days
- Class
- Class II
- Product code
- MNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002835 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK002835 BodystatBodystat, Ltd. · 2001
- This deviceK073334 Ohmniscan NGChristine Valmy, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002835 | Bodystat | Bodystat, Ltd. | 2001 | — |
| 0 (this device) | K073334 | Ohmniscan NG | Christine Valmy, Inc. | 2008 | — |
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 MNW? 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 MNW device
- #1 K231116 Multi-parameter detectorscore 11.4 · 14 generations · no Class I recall
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 |
|---|---|---|---|
| * | K002835 | BodystatSummary page 3…50. Douglas Isle Of Man British Isles, BR IM99 1 DQ Bodystat K002835 Sec 5.5- Summary and Conclusion Regarding Substantial Equivalence: By definition, a device is substantially equivalent when th… | 2001 |
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?
- Its one ancestor has no recall.
- 7 other devices also cite its predicate K002835.
How does its category compare?
All MNW devicesMNW Analyzer, Body Composition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MNW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNW
110in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNW
No recall names MNW since 2007.
Adverse event reports per year · MNW
3in 2024
MAUDE reports naming product code MNW, 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 | 4 | 109 | 0 | 0 |
| 2008 | 4 | 134 | 0 | 0 |
| 2009 | 4 | 137 | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 11 | 168 | 0 | 0 |
| 2012 | 4 | 103 | 0 | 0 |
| 2013 | 9 | 144 | 0 | 0 |
| 2014 | 3 | 110 | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Ohmnnsiscan NG is a non prescription device and is used on healthy subjects with no known disease or condition, and is identified as used for generally healthy adults (18-65). It is used to estimate the following:
* Lmpedance(Z in ohns)
* Total body water (TBW in L and in %)
* Lean Mass(LM in KG)
* Fat Mass (FM in KG and %)
* Basal Metabolism(Kcal)
* Daily energy needs(Kcal)
* B.M.I. (Body Mass Index).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073334: Ohmniscan NG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073334
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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