510(k) · Cleared
ClearedChronic Pain Suppressor CPS-2000, Model CPS-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgitech, Inc. · LIH Interferential Current Therapy
Cleared on Nov 14, 2003 as substantially equivalent to K992652 (Skylark Device & Systems Co., Ltd., 2000) and 1 other predicate after a 25-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 14, 2003
- Review
- 25 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924961 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK924961 HMP 4000 Interferential StimulatorHmp 4000, Inc. · 1993
- This deviceK033358 Chronic Pain Suppressor CPS-2000, Model CPS-2000Surgitech, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924961 | HMP 4000 Interferential Stimulator | Hmp 4000, Inc. | 1993 | — |
| 0 (this device) | K033358 | Chronic Pain Suppressor CPS-2000, Model CPS-2000 | Surgitech, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LIH? 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 LIH device
- #1 K231575 Vecttor VT-300score 7.1 · 2 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K992652 | SD-730 IF-SDS, Perfect Pulse IF-SDSSummary page 2…1-46 Predicate Device Information: Device Applicant 5 1O(k) # SD-730 Skylark Device K992652 HMP 4000 HMP 4000, Inc. K92496 1 Substantial Equivalence: The Chronic Pain Suppressor CPS-2000 is equ… | 2000 |
| * | K924961 | HMP 4000 Interferential StimulatorSummary page 2…evice Applicant 5 1O(k) # SD-730 Skylark Device K992652 HMP 4000 HMP 4000, Inc. K92496 1 Substantial Equivalence: The Chronic Pain Suppressor CPS-2000 is equivalent in basic form and function to almost any other Class… | 1993 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K992652.
How does its category compare?
All LIH devicesLIH Interferential Current Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIH
Too few LIH 510(k)s in any year since 2007 to give a median.
Recalls per year · LIH
No recall names LIH since 2007.
Adverse event reports per year · LIH
1in 2025
MAUDE reports naming product code LIH, 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 | 0 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Symptomatic relief of chronic intractable pain.
Adjunctive treatment for the management of post-traumatic or post-surgical pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033358 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033358: Chronic Pain Suppressor CPS-2000, Model CPS-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033358
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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