Medical device manufacturer
Datascope Corp.
Datascope Corp. holds 136 FDA 510(k) clearances across 34 product codes. Median elapsed review time is 90 days. openFDA lists 155 recall records naming the company. FDA publishes it under 8 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 136
- Product codes
- 34
- Median review
- 90 days
- Recall records
- 155
How does FDA spell Datascope Corp.?
FDA publishes this company under 8 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 |
|---|---|---|
| Datascope Corp | device/registrationlisting | normalised |
| Datascope Corp | device/recall | normalised |
| Datascope Corp. | device/enforcement | normalised |
| Datascope Corp. | device/recall | normalised |
| Datascope Corp. | device/registrationlisting | normalised |
| Datascope Corp. | device/510k | normalised |
| Datascope Corporation | device/recall | normalised |
| Datascope Corporation | device/enforcement | 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 Datascope Corp. file in?
34 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 64 | 95 days | |
| DQX | Wire, Guide, Catheter | 10 | 74 days | |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 7 | 22 days | |
| DYB | Introducer, Catheter | 5 | 85 days | |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 | 143 days | |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 4 | 126 days | |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 | 151 days | |
| DSI | Detector And Alarm, Arrhythmia | 3 | 87 days | |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 3 | 30 days | |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 2 | 146 days | |
| DQA | Oximeter | 2 | 96 days | |
| DSF | Recorder, Paper Chart | 2 | 22 days | |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 130 days | |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 2 | 30 days | |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 49 days | |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 1 | 72 days | |
| CCI | Analyzer, Gas, Nitrogen, Gaseous-Phase | 1 | 310 days | |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 41 days | |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 232 days | |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 92 days | |
| DQR | Cannula, Catheter | 1 | 212 days | |
| DQY | Catheter, Percutaneous | 1 | 166 days | |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 70 days | |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 5 days | |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 | 35 days |
Showing the 25 they file in most, of 34.
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 Datascope Corp. had a recall?
openFDA lists 155 recall records naming this company across its whole history, of which 7 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-1587-2026Class IIIOpen, ClassifiedDSP
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.
Z-1486-2026Class IIOpen, ClassifiedDSP
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Z-1487-2026Class IIOpen, ClassifiedDSP
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Z-0916-2026Class IIOpen, ClassifiedDSP
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Z-0917-2026Class IIOpen, ClassifiedDSP
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Showing the 5 most recently initiated of 155.
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 Datascope Corp. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool | GDW | 266 | |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | DSP | 31 | |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | DSP | 73 | |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | DSP | 46 | |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | DSP | 51 | |
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | DSP | 73 | |
| K071805 | NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX | DSI | 85 | |
| K062569 | SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING | DXC | 167 | |
| K062098 | SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX | MHX | 196 | |
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM | DSP | 44 |
Source: openFDA device/510k · retrieved
Where is Datascope Corp. registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Datascope Corp. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
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.