Tactile Systems Technology, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Tactile Systems Technology, Inc.” (first 2002, latest 2015), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 53 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 | 1 | 11 |
| 2013 | 1 | 53 |
| 2014 | 0 | — |
| 2015 | 1 | 183 |
| 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 4 | 4 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
Review panels
- Cardiovascular (4)
- Physical Medicine (1)
Most recent Tactile Systems Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143185 | entré Model PD08-U | JOW | 2015-05-07 | 183 |
| K131193 | ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM | JOW | 2013-06-18 | 53 |
| K120972 | FLEXITOUCH SYSTEM | JOW | 2012-04-13 | 11 |
| K062818 | FLEXITOUCH SYSTEM | JOW | 2006-10-06 | 16 |
| K013061 | BIOTOUCH MASSAGE THERAPY SYSTEM | IRP | 2002-07-01 | 293 |
Recalls
openFDA lists no recalls under a recalling firm named Tactile Systems Technology, 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.
SEC filings
TACTILE SYSTEMS TECHNOLOGY INC (TCMD): EDGAR filings, CIK 1027838. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tactile Medical (3 510(k)s)
- Tactile Systems Technology, Inc. (Dba Tactile Medical) (3 510(k)s)
- Tactile Technologies, Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tactile Systems Technology, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Tactile Systems Technology, Inc.” (first 2002, latest 2015), across 2 product codes in 2 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 Tactile Systems Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tactile Systems Technology, Inc. is 53 days.
Which FDA product codes appear under Tactile Systems Technology, Inc.?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 4); IRP (Massager, Powered Inflatable Tube, 1).
Next steps
- See all 5 Tactile Systems Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Tactile Systems Technology, 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.