Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Agilent Technologies, Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
101 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163367 | GenetiSure Dx Postnatal Assay | Agilent Technologies, Inc. | 2017-08-11 | 254 | 1 |
| K012094 | MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2001-07-20 | 15 | 0 |
| K011824 | AGILENT M2636B TELEMON B MONITOR (TELEMON B) | Agilent Technologies, Inc. | 2001-07-02 | 21 | 0 |
| K010634 | HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTS | Agilent Technologies, Inc. | 2001-06-11 | 101 | 1 |
| K011578 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2001-06-08 | 17 | 0 |
| K003819 | HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A | Agilent Technologies, Inc. | 2001-05-02 | 142 | 4 |
| K011093 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AN | Agilent Technologies, Inc. | 2001-05-01 | 21 | 4 |
| K010453 | M2376A DEVICELINK SYSTEM | Agilent Technologies, Inc. | 2001-03-02 | 15 | 0 |
| K010342 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2001-02-14 | 9 | 0 |
| K010048 | M2376A DEVICELINK SYSTEM | Agilent Technologies, Inc. | 2001-02-01 | 27 | 0 |
| K003621 | ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 | Agilent Technologies, Inc. | 2000-12-20 | 26 | 0 |
| K003565 | HEARTSTREAM FR2 AED, MODEL M3860A,M3861A | Agilent Technologies, Inc. | 2000-12-20 | 30 | 12 |
| K003622 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2000-12-18 | 24 | 0 |
| K002459 | PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH | Agilent Technologies, Inc. | 2000-11-08 | 90 | 0 |
| K003107 | M2376A DEVICELINK SYSTEM | Agilent Technologies, Inc. | 2000-10-19 | 15 | 0 |
| K002967 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2000-10-18 | 26 | 0 |
| K002470 | M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION | Agilent Technologies, Inc. | 2000-09-08 | 28 | 0 |
| K001725 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A | Agilent Technologies, Inc. | 2000-09-08 | 94 | 1 |
| K002397 | M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER | Agilent Technologies, Inc. | 2000-08-17 | 10 | 0 |
| K002009 | HP M2376A DEVICE LINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2000-08-02 | 30 | 0 |
| K001664 | COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL A | Agilent Technologies, Inc. | 2000-06-30 | 30 | 0 |
| K001776 | MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A | Agilent Technologies, Inc. | 2000-06-30 | 30 | 0 |
| K001711 | M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 | Agilent Technologies, Inc. | 2000-06-20 | 15 | 0 |
| K001436 | AGILENT M2636A TELEMON MONITOR | Agilent Technologies, Inc. | 2000-06-07 | 30 | 0 |
| K001348 | ST/AR ST AND ARRHYTHMIA SOFTWARE | Agilent Technologies, Inc. | 2000-05-17 | 19 | 0 |
| K001057 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AN | Agilent Technologies, Inc. | 2000-05-03 | 30 | 0 |
| K000854 | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, V | Agilent Technologies, Inc. | 2000-04-10 | 25 | 0 |
| K000635 | MODIFICATION TO HP M2376A DEVICE LINK SYSTEM | Agilent Technologies, Inc. | 2000-03-20 | 24 | 0 |
| K993907 | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 | Agilent Technologies, Inc. | 1999-12-06 | 19 | 0 |
| K854213 | ARI STANDARD ANESTHESIA RECORD | Agilent Technologies, Inc. | 1985-12-19 | 63 | 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