510(k) · Cleared
ClearedMedstar 150
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mednet Services, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Nov 20, 2001 as substantially equivalent to K950783 (U.S. Therapy Products, Inc., 1995) after a 67-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 20, 2001
- Review
- 67 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950783 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950783 4000+U.S. Therapy Products, Inc. · 1995
- This deviceK013081 Medstar 150Mednet Services, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950783 | 4000+ | U.S. Therapy Products, Inc. | 1995 | — |
| 0 (this device) | K013081 | Medstar 150 | Mednet Services, Inc. | 2001 | — |
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 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? (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 |
|---|---|---|---|
| * | K950783 | 4000+Summary page 1…r 11, 2001 MEDSTAR™ 150 Powered Muscle Stimulator (891PF) 21 CFR 890.5850, Powered Muscle Stimulator Class 11 IPF, LIH 4000+ Interferential Powered Muscle Stimulator, K950783 The MEDSTAR 150 is a DC battery powered device that generates small pulses of electrical current. These small pulses of electric… | 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?
- Its one ancestor has no recall.
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?
The MEDSTAR 150 should only be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are: e symptomatic relief and management of chronic pain and/or e an adjunctive treatment in the management of post surgical and posttraumatic acute pain. When used for neuromuscular stimulation, the standard indications for use are: e…
Read the full statement (109 words)
The MEDSTAR 150 should only be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:
e symptomatic relief and management of chronic pain and/or
e an adjunctive treatment in the management of post surgical and posttraumatic acute pain.
When used for neuromuscular stimulation, the standard indications for use are:
e Relaxation of muscle spasms
e Prevention or retardation of disuse atrophy
e Increasing local blood circulation
e Muscle re-education
e Immediate post- surglcal stimulation of calf muscles to prevent venous thrombosis; and
e Maintaining or increasing rang of motion
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013081: Medstar 150.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013081
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026