510(k) · Cleared
ClearedVibro-Trac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pneumex, Inc. · JFB Table, Physical Therapy, Multi Function
Cleared on Jun 10, 2010 as substantially equivalent to K063034 (Hill Laboratories Co., 2006) after a 279-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jun 10, 2010
- Review
- 279 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932810 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 JFB? 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 JFB device
- #1 K240168 N7-Sscore 9.8 · 7 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 |
|---|---|---|---|
| * | K063034 | Air-Flex with Auto-DistractionSummary page 1…T Table issubstantially equivalent to the following device: :2> Number ':~~ Dev ce II'Applicant K063034 Air-Flex with Auto Distraction Hill Laboratories Co. 4. indications for Use… | 2006 |
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K063034.
How does its category compare?
All JFB devicesJFB Table, Physical Therapy, Multi Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JFB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JFB
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFB
No recall names JFB since 2007.
Adverse event reports per year · JFB
1in 2024
MAUDE reports naming product code JFB, 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 | 3 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 3 | 162 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vibro-TracT m is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to ptovide patients with powered distraction and muscle relaxation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092731 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092731: Vibro-Trac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092731
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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