510(k) · Cleared
ClearedSDS-4I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skylark Device & Systems Co., Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Nov 18, 2004 as substantially equivalent to K912642 (Skylark Device Co., Ltd., 1991) and 2 other predicates after a 330-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Nov 18, 2004
- Review
- 330 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K000114 (2000). 4 ancestors in all, the oldest K912642 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000114 | RS-4M+Muscle Stimulator | Rs Medical | 2000 | — |
| −1 | K032652 | RS-4I Muscle Stimulator Family | Rs Medical | 2003 | 1 |
| 0 (this device) | K034005 | SDS-4I | Skylark Device & Systems Co., Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K912642 | EMS300, EMS400, EMS8000Summary page 1…ered Muscle stimulator" Class 11. 3. Legally Market Predicate Devices The SDS-41 is substantially equivalent to its legally marketed predecessor the EMS400 (K912642) IF- SD730 (K992652) and RS-4i (K032652) 4. Indications for Use: Indication Use For EMS (Code 10, 20-22,30-339 Only Relax mus… | 1991 |
| * | K992652 | SD-730 IF-SDS, Perfect Pulse IF-SDSSummary page 1…or" Class 11. 3. Legally Market Predicate Devices The SDS-41 is substantially equivalent to its legally marketed predecessor the EMS400 (K912642) IF- SD730 (K992652) and RS-4i (K032652) 4. Indications for Use: Indication Use For EMS (Code 10, 20-22,30-339 Only Relax muscle Spasms Prevent o… | 2000 |
| * | K032652 | RS-4I Muscle Stimulator FamilySummary page 1…egally Market Predicate Devices The SDS-41 is substantially equivalent to its legally marketed predecessor the EMS400 (K912642) IF- SD730 (K992652) and RS-4i (K032652) 4. Indications for Use: Indication Use For EMS (Code 10, 20-22,30-339 Only Relax muscle Spasms Prevent or retard disuse atro… | 2003 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
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?
Indication Use for EMS (Code 10, 20-22,30-33)
Only Relax muscle Spasms
Prevent or retard disuse atrophy
Maintain or increase range of motion
Increase local blood circulation
Re-educate muscle
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Indication Use for IF (Code 11-18, 20-22, 30-33)
For symptomatic relief and management of chronic pain and /or as an adjunctive treatment in the management of post -surgical and post-traumatic acute pain.
Powered muscle stimulators should only be used under medical supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034005 · printed Nov 3, 2026
Cite this page
510(k) Report. “K034005: SDS-4I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K034005
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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