Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synaptic Medical Corporation · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233900 | Nordica PV Cryo Mapping Catheter | Synaptic Medical Corporation | 2024-09-06 | 270 | 0 |
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | Synaptic Medical Corporation | 2024-07-26 | 178 | 0 |
| K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S | Synaptic Medical Corporation | 2024-02-16 | 88 | 0 |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | Synaptic Medical Corporation | 2022-02-14 | 413 | 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