510(k) · Cleared
ClearedGyrex 2T-Prestige
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elscint, Inc. · LNI System, Nuclear Magnetic Resonance Spectroscopic
Cleared on Mar 28, 1997 as substantially equivalent to K945791 (Elscint, Inc., 1995) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Mar 28, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- LNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930265 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK930265 Hydrogen Spectroscopy Option-Probe #M1040HS/HTGE Medical Systems · 1995
- This deviceK970005 Gyrex 2T-PrestigeElscint, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HT | GE Medical Systems | 1995 | — |
| 0 (this device) | K970005 | Gyrex 2T-Prestige | Elscint, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 LNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K945791 | Gyres 2T PrestigeSummary page 1…Inc., 505 Main St., Hackensack, NJ 07601 MAR 28 1997 1.4 510(k) Number: 2. Identification of Predicate Devices: The predicate devices are the Gyrex 2T Prestige System (k945791) and the GE Hydrogen Spectroscopy Option - PROBE (k930265). 3. Modifications to Predicate Device The current modification to th… | 1995 |
| * | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HTSummary page 1…510(k) Number: 2. Identification of Predicate Devices: The predicate devices are the Gyrex 2T Prestige System (k945791) and the GE Hydrogen Spectroscopy Option - PROBE (k930265). 3. Modifications to Predicate Device The current modification to the Gyrex 2T-Prestige consists of the addition of software t… | 1995 |
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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K945791.
How does its category compare?
All LNI devicesLNI System, Nuclear Magnetic Resonance Spectroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNI
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LNI
Too few LNI 510(k)s in any year since 2007 to give a median.
Recalls per year · LNI
12in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LNI
1in 2025
MAUDE reports naming product code LNI, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 4 | 1 |
| 2024 | 0 | — | 12 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K970005 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970005: Gyrex 2T-Prestige.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970005
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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