Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Douglas Medical Products Corp. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
163 daysmedian FDA review time
318 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961155 | SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 | Douglas Medical Products Corp. | 1996-06-18 | 88 | 0 |
| K954428 | SOLOPICC 24 (60CM) 20GA CATHETER | Douglas Medical Products Corp. | 1996-03-28 | 188 | 0 |
| K941628 | 40 MICRON BLOOD TRANSFUSION FILTER | Douglas Medical Products Corp. | 1995-02-16 | 318 | 0 |
| K942101 | 4-LEAD IRRIGATION SET | Douglas Medical Products Corp. | 1994-09-30 | 151 | 0 |
| K941453 | CHECK VALVE SOLUTION SET | Douglas Medical Products Corp. | 1994-08-16 | 144 | 0 |
| K930854 | SOLUTION SET WITH .2 MICRON FILTER | Douglas Medical Products Corp. | 1994-01-14 | 330 | 0 |
| K931659 | 3 LEAD CONNECTOR | Douglas Medical Products Corp. | 1994-01-07 | 277 | 0 |
| K932637 | SUBCUTANEOUS INFUSION SET | Douglas Medical Products Corp. | 1994-01-07 | 219 | 0 |
| K931658 | IN-LINE BURETTE SET | Douglas Medical Products Corp. | 1993-12-21 | 260 | 0 |
| K932638 | HUBER NEEDLE INFUSION SET | Douglas Medical Products Corp. | 1993-12-14 | 195 | 0 |
| K932640 | EVA EMPTY MIXING CONTAINER | Douglas Medical Products Corp. | 1993-11-10 | 161 | 0 |
| K932641 | EMPTY MIXING CONTAINER | Douglas Medical Products Corp. | 1993-11-10 | 161 | 0 |
| K925430 | LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER | Douglas Medical Products Corp. | 1993-08-03 | 280 | 0 |
| K930855 | REPLACEMENT CAP | Douglas Medical Products Corp. | 1993-07-30 | 162 | 0 |
| K926184 | DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT | Douglas Medical Products Corp. | 1993-07-27 | 231 | 0 |
| K921391 | SOLUTION ADMINISTRATION SET | Douglas Medical Products Corp. | 1992-09-02 | 163 | 0 |
| K922318 | DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET | Douglas Medical Products Corp. | 1992-08-10 | 84 | 0 |
| K920788 | BLOOD ADMINISTRATION SET | Douglas Medical Products Corp. | 1992-06-04 | 105 | 0 |
| K915560 | LO-PROFILE EXTENSION SET | Douglas Medical Products Corp. | 1992-05-14 | 155 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda