510(k) · Cleared
ClearedSurgi Stim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision Quest Industries, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Sep 14, 1998 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Sep 14, 1998
- Review
- 67 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK982388 Surgi StimVision Quest Industries, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK030507 T.E.a.R. TECH3 Model #44TT03Vision Quest Industries, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK090532 T.E.a.R. TECH3Vision Quest Industries, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK183692 Avid IF2Vision Quest Industries Inc./Dba VQ Orthocare · 2019
- Descendant · cites it directly · 0 of its ownK202490 Avid CT2Vision Quest Industries Inc./Dba VQ Orthocare · 2020
Most influential descendants
Showing 4 of 4 · See all- K030507T.E.a.R. TECH3 Model #44TT03Vision Quest Industries, Inc. · 2003 · cites it directly3descendants
- K090532T.E.a.R. TECH3Vision Quest Industries, Inc. · 2009 · 2 generations on2descendants
- K183692Avid IF2Vision Quest Industries Inc./Dba VQ Orthocare · 2019 · 2 generations on1descendant
- K202490Avid CT2Vision Quest Industries Inc./Dba VQ Orthocare · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982388 | Surgi Stim | Vision Quest Industries, Inc. | 1998 | — |
| +1 | K030507 | T.E.a.R. TECH3 Model #44TT03 | Vision Quest Industries, Inc. | 2003 | — |
| +2 | K090532 | T.E.a.R. TECH3 | Vision Quest Industries, Inc. | 2009 | — |
| +2 | K183692 | Avid IF2 | Vision Quest Industries Inc./Dba VQ Orthocare | 2019 | — |
| +1 | K202490 | Avid CT2 | Vision Quest Industries Inc./Dba VQ Orthocare | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 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, K030507 (Vision Quest Industries, Inc., 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
This device is a ‘combination’ device and has the same indications for use as two different types of predicate devices. High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below. Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion Immediate postsurgical stimulation of…
Read the full statement (99 words)
This device is a ‘combination’ device and has the same indications for use as two different types of predicate devices.
High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below.
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Interferential Stimulators have one additional indication for use:
Symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post traumatic and post-surgical pain relief.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982388 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982388: Surgi Stim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982388
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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