Data / Medical devices / United States / Douglas Medical Products, Inc
Douglas Medical Products, Inc: FDA-registered device maker in Mundelein, IL, United States, 18 510(k) clearances
Douglas Medical Products, Inc is registered with the FDA (registration 1422078) in Mundelein, IL, United States. It lists 6 device types. The FDA files 18 510(k) clearances under its listings, the newest dated July 28, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1422078
- FEI number
- 1000036860
- Address
- 361 Banbury Rd, Mundelein, IL, United States, 60060
- Owner or operator
- Douglas Medical Products, Inc. (9011133)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 28, 2015
- Registered through
- 2026
- Brand names listed
- Douglas Medical Products, TUBETECH IV Administration Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Filter, Infusion Line | FPB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Blood Transfusion | BRZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubing, Fluid Delivery | FPK | 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 |
|---|---|---|---|---|---|---|
| July 28, 2017 | K162951 | TUBETECH IV Administration Set | FPA | Substantially Equivalent | Douglas Medical Products, Inc. | accessdata.fda.gov |
| February 16, 1995 | K941628 | 40 MICRON BLOOD TRANSFUSION FILTER | FPB | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| September 30, 1994 | K942101 | 4-LEAD IRRIGATION SET | HRX | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| August 16, 1994 | K941453 | CHECK VALVE SOLUTION SET | FPA | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| January 14, 1994 | K930854 | SOLUTION SET WITH .2 MICRON FILTER | FPA | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| January 7, 1994 | K932637 | SUBCUTANEOUS INFUSION SET | FPA | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| January 7, 1994 | K931659 | 3 LEAD CONNECTOR | FPA | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| December 21, 1993 | K931658 | IN-LINE BURETTE SET | FPA | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| December 14, 1993 | K932638 | HUBER NEEDLE INFUSION SET | FPA | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| November 10, 1993 | K932641 | EMPTY MIXING CONTAINER | KPE | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| November 10, 1993 | K932640 | EVA EMPTY MIXING CONTAINER | KPE | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| August 3, 1993 | K925430 | LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER | FPA | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| July 30, 1993 | K930855 | REPLACEMENT CAP | FPA | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| July 27, 1993 | K926184 | DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT | FPA | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| September 2, 1992 | K921391 | SOLUTION ADMINISTRATION SET | FPA | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| August 10, 1992 | K922318 | DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET | HRX | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| June 4, 1992 | K920788 | BLOOD ADMINISTRATION SET | BRZ | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
| May 14, 1992 | K915560 | LO-PROFILE EXTENSION SET | FPK | Substantially Equivalent | Douglas Medical Products Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, I.V.
- All makers of Set, Administration, Intravascular
- All makers of Filter, Infusion Line
- All makers of Arthroscope
- All makers of Set, Blood Transfusion
- All makers of Tubing, Fluid Delivery
Updated July 28, 2017. 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.