Myo/Kinetic Systems, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Myo/Kinetic Systems, Inc.” (first 1992, latest 1995), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 156 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| EXY | Uroflowmeter | 1 | 1 |
| FEN | Device, Cystometric, Hydraulic | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| HIR | Perineometer | 1 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
Review panels
Most recent Myo/Kinetic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945937 | TE-800 PELVIC FLOOR EXERCISER | HIR | 1995-07-14 | 221 |
| K945292 | TS-700P CONTROL XP ELECTRICAL STIMULATOR | KPI | 1995-04-12 | 163 |
| K944972 | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY | EXY | 1995-03-08 | 148 |
| K936041 | UROGRAM CYSTOMETROGRAM | FEN | 1994-04-18 | 119 |
| K932611 | NEUROMUSCULAR STIMULATOR | GZJ | 1994-01-31 | 248 |
| K932764 | THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) | IPF | 1993-10-01 | 115 |
| K932399 | THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) | IPF | 1993-08-11 | 85 |
| K914904 | THERAPEUTIC STIMULATOR 2100 (TS-2100) | IPF | 1992-04-28 | 179 |
Recalls
openFDA lists no recalls under a recalling firm named Myo/Kinetic Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Myo/Kinetic Systems, Inc. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances are listed under Myo/Kinetic Systems, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Myo/Kinetic Systems, Inc.” (first 1992, latest 1995), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Myo/Kinetic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Myo/Kinetic Systems, Inc. is 156 days.
Which FDA product codes appear under Myo/Kinetic Systems, Inc.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 3); EXY (Uroflowmeter, 1); FEN (Device, Cystometric, Hydraulic, 1).
Next steps
- See all 8 Myo/Kinetic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Myo/Kinetic Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.