Atlas FDA

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

Agilent Technologies — Predicate Candidate Screening

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

117 daysmedian FDA review time
331 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K0109492010 PLUS HOLTER FOR WINDOWSAgilent Technologies2001-09-281830
K0039402010 PLUS HOLTER FOR WINDOWSAgilent Technologies2001-02-08490
K0037632010 PLUS HOLTER FOR WINDOWSAgilent Technologies2001-01-05300
K001308MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEWAgilent Technologies2000-05-17220
K990093ZYMED TELEMETRY SYSTEM: MODEL EASIVIEWAgilent Technologies1999-05-111200
K980186ZYMED TELEMETRY SYSTEMAgilent Technologies1998-10-072600
K942781DIGITAL HOLTER RECORDERAgilent Technologies1995-01-242250
K930806ZYMED HOLTER SCANNER MODEL 2010Agilent Technologies1994-04-254330
K924672ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY)Agilent Technologies1992-12-15900
K895208ZYMED MODEL 1610Agilent Technologies1989-12-121170
K841083QUIKPAGE ARRHYTHMIA REPORT GENERATORAgilent Technologies1985-02-073310
K822970HOLTER RECORDERAgilent Technologies1982-11-03260
K822582QUIKPAGE SCANNERAgilent Technologies1982-09-21270

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