Data / Medical devices / United States / Insightra Medical, Inc.
Insightra Medical, Inc.: FDA-registered device maker in Clarksville, TN, United States, 3 510(k) clearances
Insightra Medical, Inc. is registered with the FDA (registration 2032677) in Clarksville, TN, United States. It lists 11 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 24, 2010. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2032677
- FEI number
- 3003945344
- Address
- 2543 Madison St Unit 105, Clarksville, TN, United States, 37043
- Owner or operator
- INSIGHTRA MEDICAL, INC. (9054804)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 10, 2003
- Registered through
- 2026
- Brand names listed
- Arthroscope, Catheter, Double Pump Cassettes, Hemostasis Y Connector Kit, INSTRUMENT, MANUAL, Insightra Balloon Inflation Device, Ligator, Retractor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Accessories, Catheter | KGZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Endoscopic Contamination Prevention Sheath | ODB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Syringe, Balloon Inflation, Exempt | PTM | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Balloon, Intra-Aortic And Control | DSP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2010 | K093409 | POWERPUMP ARTHROSCOPY SYSTEM | HRX | Substantially Equivalent | Medical Vision AB | accessdata.fda.gov |
| January 12, 2009 | K082746 | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | DSP | Substantially Equivalent | Insightra Medical, Inc. | accessdata.fda.gov |
| June 10, 2008 | K080550 | MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 | ODB | Substantially Equivalent | Minos Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 19, 2025 | 97246 | Class II | Terminated | Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ult | Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Accessories, Catheter
- All makers of Accessories, Arthroscopic
- All makers of Endoscopic Contamination Prevention Sheath
- All makers of Arthroscope
- All makers of Ligator, Hemorrhoidal
Updated August 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.