Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Calypso Medical Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
140 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112841 | SURFACE BEACON TRANSPONDERS | Calypso Medical Technologies, Inc. | 2012-02-16 | 140 | 0 |
| K112768 | CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING | Calypso Medical Technologies, Inc. | 2011-11-18 | 57 | 0 |
| K102373 | CALYPSO SYSTEM WITH DYNAMIC EDGE GATING | Calypso Medical Technologies, Inc. | 2010-09-30 | 41 | 0 |
| K080726 | CALYPSO 4D LOCALIZATION SYSTEM | Calypso Medical Technologies, Inc. | 2008-05-14 | 61 | 0 |
| K060906 | CALYPSO 4D LOCALIZATION SYSTEM | Calypso Medical Technologies, Inc. | 2006-07-28 | 116 | 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