510(k) · Cleared
ClearedHPM-6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Oct 21, 2016 as substantially equivalent to K973929 (Neotonus, Inc., 1998) and 1 other predicate after a 196-day review. Its family tree reaches back 1 generation to 1995. 18 later devices descend from it.
- Decided
- Oct 21, 2016
- Review
- 196 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952089 (1995). 2 ancestors in all. 18 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK952089 Rich-Mar CM-II Combined Muscle Stimulator, Interferential, Tens &…Rich-Mar Corp. · 1995
- This deviceK160992 HPM-6000BTL Industries, Inc. · 2016
- Descendant · cites it directly · 11 of its ownK190456 BTL 799-2LBTL Industries, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK203710 Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021
- Descendant · 2 generations on · 4 of its ownK200382 BTL-703-2Btl · 2021
- Descendant · cites it directly · 3 of its ownK203488 emFieldZimmer Medizinsysteme GmbH · 2021
- Descendant · 2 generations on · 2 of its ownK240234 BTL-899MSBTL Industries, Inc. · 2024
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K190456BTL 799-2LBTL Industries, Inc. · 2019 · cites it directly11descendants
- K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021 · cites it directly4descendants
- K200382BTL-703-2Btl · 2021 · 2 generations on4descendants
- K203488emFieldZimmer Medizinsysteme GmbH · 2021 · cites it directly3descendants
- K240234BTL-899MSBTL Industries, Inc. · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952089 | Rich-Mar CM-II Combined Muscle Stimulator, Interferential, Tens & Therapeutic… | Rich-Mar Corp. | 1995 | — |
| 0 (this device) | K160992 | HPM-6000 | BTL Industries, Inc. | 2016 | — |
| +1 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| +1 | K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | 2021 | — |
| +2 | K200382 | BTL-703-2 | Btl | 2021 | — |
| +1 | K203488 | emField | Zimmer Medizinsysteme GmbH | 2021 | — |
| +2 | K240234 | BTL-899MS | BTL Industries, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K973929 | Neotonus MS-101 Magnetic Muscle Stimulator SystemSummary page 5…f 6 0 510(K) SUMMARY • Neotonus MS-101 Magnetic Muscle Stimulator System (K973929) Product Description The HPM-6000 is a non-invasive therapeutic device. The device produces electromagnetic field that interact… | 1998 |
| * | K952089 | Rich-Mar CM-II Combined Muscle Stimulator, Interferential, Tens & Therapeutic Ultrasound…Summary page 9…inciples of operation as its predicate device. One of the technological differences between the subject and predicate devices includes pulse repetition rate. Therefore, K952089, a powered muscle stimulator cleared under the IPF product code (predicate of the predicate or K952089) has been submitted to dem… | 1995 |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
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. 2016, this device’s year, is highlighted.
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 HPM-6000 device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The HPM-6000 device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160992 · printed Nov 3, 2026
Cite this page
510(k) Report. “K160992: HPM-6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K160992
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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