Douglas Medical Products, Inc
Mundelein, IL, US
DOUGLAS MEDICAL PRODUCTS, INC appears in FDA device records in Mundelein, IL. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for Douglas Medical Products, Inc between 1992 and 2017. The busiest year on record is 1993, with 7. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 4 |
| 1993 | 7 |
| 1994 | 5 |
| 1995 | 1 |
| 1996 | 2 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162951 | TUBETECH IV Administration Set | FPA | Substantially Equivalent | |
| K961155 | SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 | LJS | Substantially Equivalent | |
| K954428 | SOLOPICC 24 (60CM) 20GA CATHETER | FOZ | Substantially Equivalent | |
| K941628 | 40 MICRON BLOOD TRANSFUSION FILTER | FPB | Substantially Equivalent | |
| K942101 | 4-LEAD IRRIGATION SET | HRX | Substantially Equivalent | |
| K941453 | CHECK VALVE SOLUTION SET | FPA | Substantially Equivalent | |
| K930854 | SOLUTION SET WITH .2 MICRON FILTER | FPA | Substantially Equivalent | |
| K932637 | SUBCUTANEOUS INFUSION SET | FPA | Substantially Equivalent | |
| K931659 | 3 LEAD CONNECTOR | FPA | Substantially Equivalent | |
| K931658 | IN-LINE BURETTE SET | FPA | Substantially Equivalent | |
| K932638 | HUBER NEEDLE INFUSION SET | FPA | Substantially Equivalent | |
| K932641 | EMPTY MIXING CONTAINER | KPE | Substantially Equivalent | |
| K932640 | EVA EMPTY MIXING CONTAINER | KPE | Substantially Equivalent | |
| K925430 | LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER | FPA | Substantially Equivalent | |
| K930855 | REPLACEMENT CAP | FPA | Substantially Equivalent | |
| K926184 | DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT | FPA | Substantially Equivalent | |
| K921391 | SOLUTION ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K922318 | DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET | HRX | Substantially Equivalent | |
| K920788 | BLOOD ADMINISTRATION SET | BRZ | Substantially Equivalent | |
| K915560 | LO-PROFILE EXTENSION SET | FPK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1422078 | 1000036860 | DOUGLAS MEDICAL PRODUCTS, INC | 361 Banbury Rd, Mundelein, IL 60060 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain