510(k) · Cleared
ClearedFT2000 Sequencer for Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midwest Development · IPF Stimulator, Muscle, Powered
Cleared on May 23, 2005 as substantially equivalent to K972244 (Bio-Medical Research, Ltd., 1998) after a 76-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- May 23, 2005
- Review
- 76 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912178 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K972244 | NT2000Summary page 1…Product Code: IPF, 21 CFR § 890.5850 Class: Class II (3) Predicate Device(s): K972244 NT2000, Bio-Medical Research, Ltd. Reason for Submission: New Device (4) Description… | 1998 |
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 14 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K972244.
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?
When used in combination with a listed stimulator, such as the NT2000 manufactured by Bio-Medical Research Ltd., the Midwest Development FT2000 Sequencer provides electrical neuromuscular stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, or to maintain or increase range of motion. Sequencing provided by the FT2000 directs the stimulator…
Read the full statement (119 words)
When used in combination with a listed stimulator, such as the NT2000 manufactured by Bio-Medical Research Ltd., the Midwest Development FT2000 Sequencer provides electrical neuromuscular stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, or to maintain or increase range of motion.
Sequencing provided by the FT2000 directs the stimulator signal from the stimulator device to selected patient electrode sites without modifying the original signal characteristics.
The FT2000 permits treatment in user selected time sequences of up to 24 pairs of electrodes by having 12 pairs on each side of the body. The C12000 Software allows the user to set treatment times for each electrode pair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050595 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050595: FT2000 Sequencer for Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050595
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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