Data / Medical devices / United States / Ohio Medical LLC
Ohio Medical LLC: FDA-registered device maker in Gurnee, IL, United States, 6 510(k) clearances
Ohio Medical LLC is registered with the FDA (registration 1419185) in Gurnee, IL, United States. It lists 9 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 1, 2018. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1419185
- Address
- 1111 Lakeside DR, Gurnee, IL, United States, 60031
- Owner or operator
- OHIO MEDICAL LLC (1419185)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 3, 1992
- Registered through
- 2026
- Brand names listed
- Amvex Compact Gas Regulators, Amvex Dial Flowmeter, Amvex Flowmeter, Amvex Medical Gas Regulators, Amvex Vacuum Regulators, CARE-E-VAC 3, Disposable Collection Bottles, Filter and Tubing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | CCN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | 1 | Manufacturer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Regulator, Vacuum | KDP | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer | 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 1, 2018 | K172234 | Oxygen Concentrator | CAW | Substantially Equivalent | Sysmed (China) Co., Ltd. | accessdata.fda.gov |
| May 24, 2017 | K162433 | GCE Zen-O Portable Oxygen Concentrator | CAW | Substantially Equivalent | Oxus, Inc. | accessdata.fda.gov |
| April 27, 2010 | K093241 | V7 PORTABLE SUCTION UNITS | BTA | Substantially Equivalent | Hersill, S.L. | accessdata.fda.gov |
| September 28, 2006 | K062610 | CARE-E-VAC 3 | BTA | Substantially Equivalent | Ohio Medical Corporation | accessdata.fda.gov |
| May 20, 1994 | K933902 | MOBLVAC III | BTA | Substantially Equivalent | Aeros Instruments, Inc. | accessdata.fda.gov |
| November 12, 1993 | K932051 | TOTE-L-VAC | BTA | Substantially Equivalent | Aeros Instruments, 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 |
|---|---|---|---|---|---|---|
| May 8, 2025 | 96851 | Class II | Ongoing | GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S | Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect. | accessdata.fda.gov |
| November 16, 2021 | 88984 | Class II | Ongoing | Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000. | Increase in premature device failures | accessdata.fda.gov |
| August 14, 2018 | 80785 | Class II | Terminated | Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodi | The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power. | accessdata.fda.gov |
| March 12, 2018 | 80294 | Class II | Terminated | Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body. | Final quality control testing was not completed before the devices were distributed.. | accessdata.fda.gov |
| November 8, 2010 | 57196 | Not yet classified | Terminated | Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000 The device is a portable aspirator to help evacuate saliva, mucous, vomit or oth | The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened. | accessdata.fda.gov |
| May 10, 2010 | 55638 | Not yet classified | Terminated | MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical Corporation, Gurnee, IL 60031; Models 769600 (with Truseal), 75960 | Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use. | accessdata.fda.gov |
| September 21, 2009 | 53192 | Not yet classified | Terminated | Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0301-600 (6700-0206-500); the bottles are sold alone and with various cap & float assemblies including: 0321-7986-8 | The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Regulator, Vacuum
- All makers of Generator, Oxygen, Portable
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
- All makers of Bottle, Collection, Vacuum
- All makers of Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Updated June 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.