Medical device manufacturer
Hewlett-Packard GmbH
Hewlett-Packard GmbH holds 246 FDA 510(k) clearances across 57 product codes. Median elapsed review time is 84 days. openFDA lists no recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 246
- Product codes
- 57
- Median review
- 84 days
- Recall records
- 0
How does FDA spell Hewlett-Packard GmbH?
FDA publishes this company under 2 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Hewlett-Packard Co. | device/510k | normalised |
| Hewlett-Packard GmbH | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Hewlett-Packard GmbH file in?
57 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 22 | 90 days | |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 20 | 53 days | |
| DPS | Electrocardiograph | 15 | 35 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 14 | 84 days | |
| HGM | System, Monitoring, Perinatal | 13 | 85 days | |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 10 | 156 days | |
| DQA | Oximeter | 8 | 67 days | |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 8 | 195 days | |
| DXJ | Display, Cathode-Ray Tube, Medical | 7 | 33 days | |
| ITX | Transducer, Ultrasonic, Diagnostic | 7 | 80 days | |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 6 | 24 days | |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 6 | 56 days | |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 6 | 69 days | |
| MKJ | Automated External Defibrillators (Non-Wearable) | 6 | 87 days | |
| DQK | Computer, Diagnostic, Programmable | 5 | 97 days | |
| DRR | Amplifier And Signal Conditioner, Biopotential | 5 | 15 days | |
| DRS | Transducer, Blood-Pressure, Extravascular | 5 | 126 days | |
| DRX | Electrode, Electrocardiograph | 5 | 92 days | |
| DSF | Recorder, Paper Chart | 5 | 24 days | |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 4 | 90 days | |
| DXK | Echocardiograph | 4 | 52 days | |
| KIE | Apparatus, High Pressure Liquid Chromatography | 4 | 13 days | |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 3 | 17 days | |
| DPT | Probe, Blood-Flow, Extravascular | 3 | 90 days | |
| DXQ | Blood Pressure Cuff | 3 | 42 days |
Showing the 25 they file in most, of 57.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Hewlett-Packard GmbH had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Hewlett-Packard GmbH cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K992543 | HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE | MKJ | 293 | |
| K993383 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B | DSI | 118 | |
| K992273 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B | MHX | 205 | |
| K993587 | HP M2376A DEVICE LINK SYSTEM | MQS | 90 | |
| K993169 | MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A | DRG | 89 | |
| K992595 | HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH | MHX | 127 | |
| K992977 | HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A | MKJ | 89 | |
| K993516 | HP M2600A VIRIDIA TELEMETRY SYSTEM | DSI | 21 | |
| K992674 | HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A | MHX | 90 | |
| K993171 | HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A | DSI | 30 |
Source: openFDA device/510k · retrieved
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.