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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Equidyne Systems, Inc. — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

83 daysmedian FDA review time
260 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K022502INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000Equidyne Systems, Inc.2002-09-05380
K022148INJEX 30 NEEDLE FREE INJECTION SYSTEMEquidyne Systems, Inc.2002-07-23210
K003741JET SYRINGE MODEL-100500Equidyne Systems, Inc.2001-06-011790
K003864INJEX 50 SYSTEMEquidyne Systems, Inc.2001-03-06830
K945873HYPEX(TM) JET INJECTOREquidyne Systems, Inc.1995-08-182600

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