Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Panamedix, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
267 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871848 | NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP | Panamedix, Inc. | 1988-02-03 | 267 | 0 |
| K871843 | TWO FLUID W/CHECK VALVE | Panamedix, Inc. | 1987-07-21 | 70 | 0 |
| K871842 | TWO FLUID I.V. SETS | Panamedix, Inc. | 1987-06-24 | 43 | 0 |
| K871841 | THREE FLUID I.V. SETS | Panamedix, Inc. | 1987-06-24 | 43 | 0 |
| K865051 | GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP | Panamedix, Inc. | 1987-02-10 | 48 | 0 |
| K864395 | LOW VOLUME EXTENSION SET | Panamedix, Inc. | 1986-12-16 | 40 | 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