Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Zymed Medical Instrumentation · Predicate Candidate Screening

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

92 daysmedian FDA review time
252 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K002004ZYBITZymed Medical Instrumentation2000-09-21800
K992197MODIFICATION TO ZYMED HOLTER 2000Zymed Medical Instrumentation1999-07-28280
K990170HOLTER 2000Zymed Medical Instrumentation1999-04-13840
K984089ZYMED TELEMETRY SYSTEM, MODEL EASI VIEWZymed Medical Instrumentation1999-02-16920
K955015ZYMED HOLTER SCANNER MODEL 2010Zymed Medical Instrumentation1996-03-181380
K951370ZYMED TELEMETRY SYSTEM; MODEL T8010Zymed Medical Instrumentation1995-10-061930
K930894MULTITRAK-PLUSZymed Medical Instrumentation1993-11-012520

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