Hewlett-Packard Co.: FDA clearances and approvals
Hewlett-Packard Co. has 246 FDA 510(k) clearances (first 1976, latest 2000), across 59 product codes in 9 review panels. Median 510(k) review time: 84 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 22 | 22 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 20 | 20 |
| DPS | Electrocardiograph | 15 | 15 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 14 | 14 |
| HGM | System, Monitoring, Perinatal | 13 | 13 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 10 | 10 |
| DQA | Oximeter | 8 | 8 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 8 | 8 |
| DXJ | Display, Cathode-Ray Tube, Medical | 7 | 7 |
| ITX | Transducer, Ultrasonic, Diagnostic | 7 | 7 |
Plus 49 more product codes.
Review panels
- Cardiovascular (148)
- Radiology (31)
- Anesthesiology (24)
- Obstetrics and Gynecology (17)
- Clinical Toxicology (11)
- Gastroenterology and Urology (4)
- Clinical Chemistry (1)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Hewlett-Packard Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992543 | HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE | MKJ | 2000-05-18 | 293 |
| K993383 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B | DSI | 2000-02-03 | 118 |
| K992273 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B | MHX | 2000-01-28 | 205 |
| K993587 | HP M2376A DEVICE LINK SYSTEM | MQS | 2000-01-20 | 90 |
| K993169 | MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A | DRG | 1999-12-20 | 89 |
| K992595 | HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH | MHX | 1999-12-08 | 127 |
| K992977 | HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A | MKJ | 1999-12-01 | 89 |
| K993516 | HP M2600A VIRIDIA TELEMETRY SYSTEM | DSI | 1999-11-08 | 21 |
| K992674 | HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A | MHX | 1999-11-08 | 90 |
| K993171 | HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A | DSI | 1999-10-21 | 30 |
236 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hewlett-Packard Co..
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.
Frequently asked questions
How many FDA 510(k) clearances does Hewlett-Packard Co. have?
Hewlett-Packard Co. has 246 FDA 510(k) clearances (first 1976, latest 2000), across 59 product codes in 9 review panels.
How long does FDA take to clear Hewlett-Packard Co.'s 510(k)s?
The median time from FDA receipt to decision across Hewlett-Packard Co.'s cleared 510(k)s is 84 days.
What devices does Hewlett-Packard Co. make?
Its most frequent FDA product codes are DSI (Detector And Alarm, Arrhythmia, 22); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 20); DPS (Electrocardiograph, 15).
Has Hewlett-Packard Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hewlett-Packard Co. Related entities may recall under other names.
Next steps
- See all 246 Hewlett-Packard Co. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Hewlett-Packard Co.'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.