Agilent Technologies, Inc.: FDA clearances and approvals
Agilent Technologies, Inc. has 45 FDA 510(k) clearances (first 1982, latest 2017), plus 6 PMA decisions, across 20 product codes in 5 review panels. Median 510(k) review time: 30 days. openFDA lists 5 product recalls by a recalling firm named Agilent Technologies, Inc. It files with the SEC as AGILENT TECHNOLOGIES, INC. (A).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 254 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Agilent Technologies, Inc.'s cleared 510(k)s took a median 254 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 11 | 11 |
| DSI | Detector And Alarm, Arrhythmia | 9 | 9 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 5 | 5 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 4 | 4 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 | 3 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 3 | 3 |
| DPS | Electrocardiograph | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 | 1 |
Plus 10 more product codes.
Review panels
- Cardiovascular (37)
- Pathology (6)
- Anesthesiology (3)
- Radiology (3)
- General Hospital (1)
Most recent Agilent Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163367 | GenetiSure Dx Postnatal Assay | PFX | 2017-08-11 | 254 |
| K010949 | 2010 PLUS HOLTER FOR WINDOWS | MLO | 2001-09-28 | 183 |
| K012094 | MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A | MWI | 2001-07-20 | 15 |
| K011824 | AGILENT M2636B TELEMON B MONITOR (TELEMON B) | DSI | 2001-07-02 | 21 |
| K010634 | HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B | MKJ | 2001-06-11 | 101 |
| K011578 | M2376A DEVICELINK SYSTEM, MODEL M2376A | MWI | 2001-06-08 | 17 |
| K003819 | HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A | MKJ | 2001-05-02 | 142 |
| K011093 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 | MHX | 2001-05-01 | 21 |
| K010453 | M2376A DEVICELINK SYSTEM | MWI | 2001-03-02 | 15 |
| K010342 | M2376A DEVICELINK SYSTEM, MODEL M2376A | MWI | 2001-02-14 | 9 |
35 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250004 | PMA | MMR IHC Panel pharmDx (Dako Omnis) | 2025-08-15 |
| P230016 | PMA | MAGE-A4 IHC 1F9 pharmDx | 2024-08-01 |
| P210026 | PMA | Ki-67 IHC pharmDx | 2021-10-12 |
| P150025 | PMA | PD-L1 IHC 28-8 pharmDx | 2015-10-09 |
| P150013 | PMA | PD-L1 IHC 22C3 PHARMDX | 2015-10-02 |
Recalls
5 product recalls in 5 recall events; 3 initiated in the last five years. Most recent: 2025-03-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
AGILENT TECHNOLOGIES, INC. (A): EDGAR filings, CIK 1090872. Matched by exact company name.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Agilent Technologies, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Agilent Technologies, Inc. have?
Agilent Technologies, Inc. has 45 FDA 510(k) clearances (first 1982, latest 2017), plus 6 PMA decisions, across 20 product codes in 5 review panels.
How long does FDA take to clear Agilent Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Agilent Technologies, Inc.'s cleared 510(k)s is 30 days.
What devices does Agilent Technologies, Inc. make?
Its most frequent FDA product codes are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 11); DSI (Detector And Alarm, Arrhythmia, 9); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 5).
Has Agilent Technologies, Inc. had device recalls?
openFDA lists 5 product recalls in 5 recall events by a recalling firm whose name matches Agilent Technologies, Inc; the most recent began 2025-03-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 45 Agilent Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MWI, Agilent Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.