510(k) · Cleared
ClearedStellar Model HS-04
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stellar Medical Corp. · IPF Stimulator, Muscle, Powered
Cleared on Feb 18, 1998 as substantially equivalent to K953136 (Rs Medical, 1995) and 2 other predicates after a 175-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Feb 18, 1998
- Review
- 175 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K926510 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K990697RS-4V Muscle StimulatorRs Medical · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926510 | Staodyn Ems+2 | Staodyne, Inc. | 1993 | — |
| 0 (this device) | K973223 | Stellar Model HS-04 | Stellar Medical Corp. | 1998 | — |
| +1 | K990697 | RS-4V Muscle Stimulator | Rs Medical | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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? (3)
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 |
|---|---|---|---|
| * | K953136 | RS-4MSummary page 1…tact: B. C. James, M.D., Prepared: August 26, 1997 LEGALLY MARKETED PREDICATE DEVICES The Stellar Model HS-04 is substantially equivalent to the RS Medical Mode! RS-4M (K953136) and the Staodyn EMS + 2 (K926510) electrical stimulators with respect to its stimulation functions and is substantially equivale… | 1995 |
| * | K926510 | Staodyn Ems+2Summary page 1…August 26, 1997 LEGALLY MARKETED PREDICATE DEVICES The Stellar Model HS-04 is substantially equivalent to the RS Medical Mode! RS-4M (K953136) and the Staodyn EMS + 2 (K926510) electrical stimulators with respect to its stimulation functions and is substantially equivalent to the PT-PAC Portable Heating… | 1993 |
| * | K963887 | PT-Pac Portable Heating PadSummary page 1…6) and the Staodyn EMS + 2 (K926510) electrical stimulators with respect to its stimulation functions and is substantially equivalent to the PT-PAC Portable Heating Pad (K963887)with respect to its heating functions. DEVICE DESCRIPTION The Stellar Model HS-04 is a device that combines the functionality o… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990697 | RS-4V Muscle Stimulator | 1999 | 0 |
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?
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 Stellar Model HS-04 stimulator mode is indicated for use in repeatedly contracting muscles using pulsed electrical currents for muscle reeducation, maintaining or increasing range of motion, relaxing muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and immediate post-surgical prevention of venous thrombosis in the calf. The Stellar Model HS-04 interferrential mode is indicated for use in post-surgical…
Read the full statement (110 words)
The Stellar Model HS-04 stimulator mode is indicated for use in repeatedly contracting muscles using pulsed electrical currents for muscle reeducation, maintaining or increasing range of motion, relaxing muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and immediate post-surgical prevention of venous thrombosis in the calf.
The Stellar Model HS-04 interferrential mode is indicated for use in post-surgical acute pain and edema, post-traumatic acute pain and edema, reduction of inflamation, increasing local blood circulation, maintaining or increasing range of motion, and relaxing muscle spasms.
The Stellar Model HS-04 heating-mode is indicated for heating of a body region for the relief of minor muscular or joint pain.
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/K973223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973223: Stellar Model HS-04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973223
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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