Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Plasmedics, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
143 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853559 | STERILE BIOPSY NEEDLES | Plasmedics, Inc. | 1985-09-11 | 16 | 0 |
| K850263 | PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY | Plasmedics, Inc. | 1985-03-25 | 61 | 0 |
| K831601 | APNEA ALARM FOR ADULT-PEDIATRIC & NEON | Plasmedics, Inc. | 1983-09-26 | 131 | 0 |
| K831650 | ANESTHESIA/RESPIRATORY DISCONNECT - | Plasmedics, Inc. | 1983-09-12 | 112 | 0 |
| K830604 | WEDGE PRESSURE CATHETER | Plasmedics, Inc. | 1983-07-18 | 143 | 0 |
| K823351 | CENTRAL VENOUS CATHETER | Plasmedics, Inc. | 1982-12-09 | 30 | 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