Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Distronic Sterile Products, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
167 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955709 | WINGED & SUBCUTANEOUS INFUSION SETS | Distronic Sterile Products, Inc. | 1996-02-21 | 65 | 0 |
| K955732 | VENTED SOLUTION SET | Distronic Sterile Products, Inc. | 1996-02-21 | 64 | 0 |
| K954983 | EXTENSION SET WITH CHECK VALVE | Distronic Sterile Products, Inc. | 1996-01-23 | 84 | 0 |
| K954984 | MINIBORE STOPCOCK SET | Distronic Sterile Products, Inc. | 1996-01-23 | 84 | 0 |
| K952664 | SOLUTION ADMINISTRATION SET | Distronic Sterile Products, Inc. | 1995-08-07 | 56 | 0 |
| K950597 | CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE | Distronic Sterile Products, Inc. | 1995-07-26 | 167 | 0 |
| K952663 | 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENS | Distronic Sterile Products, Inc. | 1995-07-14 | 32 | 0 |
| K945184 | INTRAVASCULAR ADMINISTRATION SET | Distronic Sterile Products, Inc. | 1995-02-08 | 107 | 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