Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Parker Hannifin Corp. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
282 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161731 | Cleveland Multiport Ventricular Catheter Set | Parker Hannifin Corp. | 2017-03-27 | 277 | 0 |
| K897086 | PARKER AMBULATORY MEDICATION INFUSION PUMP 2004 | Parker Hannifin Corp. | 1990-09-28 | 282 | 0 |
| K863532 | MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER | Parker Hannifin Corp. | 1987-01-14 | 127 | 0 |
| K834461 | INFUSION PUMP PRIMER | Parker Hannifin Corp. | 1984-01-30 | 42 | 0 |
| K833723 | MODEL 2000 AMBULATORY MED. INFUSER | Parker Hannifin Corp. | 1984-01-30 | 98 | 0 |
| K831402 | PRESSURE MONITOR & CONTROL UNIT APC-02A | Parker Hannifin Corp. | 1983-08-08 | 98 | 0 |
| K831747 | PLASMA THERAPY TUBESET-E100 SERIES | Parker Hannifin Corp. | 1983-06-30 | 29 | 0 |
| K830818 | ASAHI BLOOD/PLASMA PUMP #ABP-01A & | Parker Hannifin Corp. | 1983-04-12 | 28 | 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