Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PKP — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
243 daysmedian FDA review time
366 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025-12-22 | 255 | 0 |
| K240148 | SCIg60 Infusion System | Emed Technologies Corporation | 2024-02-16 | 28 | 0 |
| K230883 | VersaPump Infusion System | Emed Technologies Corporation | 2023-11-28 | 243 | 0 |
| K222087 | SCIg60 Infusion System | Emed Technologies Corporation | 2022-10-13 | 90 | 0 |
| K173783 | SCIg60 Infusion System | Emed Technologies Corporation | 2018-12-14 | 366 | 0 |
| K161906 | SCIg60 Infuser | Emed Technologies Corporation | 2016-12-01 | 142 | 0 |
| K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | 2015-05-14 | 267 | 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