Data / Medical devices / United States / Sterilmed, Inc.
Sterilmed, Inc.: FDA-registered device maker in Plymouth, MN, United States, 24 510(k) clearances
Sterilmed, Inc. is registered with the FDA (registration 3011276773) in Plymouth, MN, United States. It lists 8 device types. The FDA files 24 510(k) clearances under its listings, the newest dated June 29, 2026. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011276773
- Address
- 5010 Cheshire Pkwy N Ste 2, Plymouth, MN, United States, 55446
- Owner or operator
- STERILMED, INC. (9030419)
- Roles
- Reprocessor, Specification developer
- First device listed
- July 1, 2003
- Registered through
- 2026
- Brand names listed
- EP Catheter, MAXFRAME, Reprocessed AcuNav CRYSTAL Ultrasound Catheter, Reprocessed DECANAV Electrophysiology Catheter, Reprocessed EP Catheter, Reprocessed EP Catheters, Reprocessed External Fixation Device, Reprocessed Imaging Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Reprocessor, Specification developer | accessdata.fda.gov |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 2 | Reprocessor, Specification developer | accessdata.fda.gov |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | 2 | Reprocessor, Specification developer | accessdata.fda.gov |
| Catheter, Intracardiac Mapping, High-Density, Reprocessed | NLG | 2 | Reprocessor, Specification developer | accessdata.fda.gov |
| Catheter, Recording, Electrode, Reprocessed | NLH | 2 | Reprocessor, Specification developer | accessdata.fda.gov |
| Reprocessed Bronchoscope | QNW | 2 | Reprocessor | accessdata.fda.gov |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | 2 | Reprocessor, Specification developer | accessdata.fda.gov |
| Software For Diagnosis/Treatment | OSN | 2 | Reprocessor, 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 |
|---|---|---|---|---|---|---|
| June 29, 2026 | K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | OWQ | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| October 11, 2024 | K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | NLH | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| November 28, 2023 | K231473 | Monarch Bronchoscope | QNW | Substantially Equivalent | Auris Health, Inc., A Johnson and Johnson Family Company | accessdata.fda.gov |
| June 23, 2021 | K201806 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | MTD | Substantially Equivalent | Sterilmed Inc. (Johnson and Johnson) | accessdata.fda.gov |
| March 11, 2021 | K203614 | Monarch Bronchoscope | QNW | Substantially Equivalent | Auris Health, Inc., A Johnson and Johnson Family Company | accessdata.fda.gov |
| November 14, 2019 | K190478 | Reprocessed ViewFlex Xtra ICE Catheter | OWQ | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| November 21, 2016 | K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | OWQ | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| November 10, 2016 | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | KTT | Substantially Equivalent | Synthes USA, LLC | accessdata.fda.gov |
| June 23, 2016 | K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | NLH | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| August 27, 2015 | K150357 | Reprocessed Electrophysiology Diagnostic Catheters | NLH | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| August 6, 2012 | K121158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| August 18, 2011 | K110076 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER | OWQ | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| August 19, 2010 | K101789 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| January 14, 2010 | K092158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| March 2, 2009 | K083636 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| August 18, 2008 | K081586 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| August 13, 2008 | K081342 | REPROCESSED EXTERNAL FIXATION ACCESSORIES | KTT | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| September 21, 2005 | K051957 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | Substantially Equivalent | Sterilemed, Inc. | accessdata.fda.gov |
| June 14, 2005 | K051220 | REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| March 1, 2005 | K043513 | STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER | NLH | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| March 1, 2005 | K043453 | STERILEMED REPROCESSED IVUS IMAGING CATHETER | OWQ | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| October 11, 2002 | K012537 | REPROCESSED IMAGING CATHETERS | OWQ | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| August 14, 2002 | K012678 | REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
| August 14, 2002 | K012523 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | Substantially Equivalent | Sterilmed, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 8, 2025 | 97803 | Class II | Ongoing | Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Soft | Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism. | accessdata.fda.gov |
| September 17, 2018 | 80999 | Class II | Terminated | Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve | Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing. | accessdata.fda.gov |
| June 2, 2017 | 77470 | Class I | Terminated | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Pro | Inadequate seal due to lack of adhesive glue | accessdata.fda.gov |
| May 8, 2017 | 77190 | Class II | Terminated | Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They eithe | Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Recording, Electrode, Reprocessed
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Reprocessed Bronchoscope
- All makers of Reprocessed Intravascular Ultrasound Catheter
- All makers of Catheter, Intracardiac Mapping, High-Density, Reprocessed
- All makers of Catheter, Intracardiac Mapping, High-Density Array
Updated June 29, 2026. 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.