Datascope Corp.: FDA filings under this applicant name
FDA lists 136 510(k) clearances under the applicant name “Datascope Corp.” (first 1976, latest 2019), plus 1 PMA decision, across 36 product codes in 5 review panels. Median 510(k) review time under this name: 91 days. Since 2017 the median was 60 days, against 145 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 73 |
| 2014 | 0 | — |
| 2015 | 1 | 51 |
| 2016 | 0 | — |
| 2017 | 2 | 60 |
| 2018 | 1 | 31 |
| 2019 | 1 | 266 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Datascope Corp. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 64 | 64 |
| DQX | Wire, Guide, Catheter | 10 | 10 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 7 | 7 |
| DYB | Introducer, Catheter | 5 | 5 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 | 4 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 4 | 4 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 3 | 3 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 2 | 2 |
Plus 26 more product codes.
Review panels
- Cardiovascular (117)
- Anesthesiology (11)
- General Hospital (3)
- General and Plastic Surgery (2)
- Gastroenterology and Urology (1)
Most recent Datascope Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool | GDW | 2019-12-26 | 266 |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | DSP | 2018-05-31 | 31 |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | DSP | 2017-10-12 | 73 |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | DSP | 2017-01-31 | 46 |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | DSP | 2015-07-02 | 51 |
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | DSP | 2013-12-12 | 73 |
| K071805 | NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX | DSI | 2007-09-25 | 85 |
| K062569 | SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING | DXC | 2007-02-14 | 167 |
| K062098 | SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX | MHX | 2007-02-05 | 196 |
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM | DSP | 2007-01-05 | 44 |
126 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P850023 | PMA | HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT | 1986-05-27 |
Recalls
155 product recalls in 60 recall events; 57 initiated in the last five years. Most recent: 2026-02-06.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Datascope Corp. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00833612: Counterpulsation Reduces Infarct Size Pre-PCI for AMI (Completed, started 2008-12)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Datascope Corp., Cardiac Assist Division (4 510(k)s)
- Datascope Corp., Patient Monitoring Division (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Datascope Corp.?
FDA lists 136 510(k) clearances under the applicant name “Datascope Corp.” (first 1976, latest 2019), plus 1 PMA decision, across 36 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Datascope Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Datascope Corp. is 91 days. Since 2017: 60 days, versus 145 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Datascope Corp.?
The most frequent FDA product codes under this applicant name are DSP (System, Balloon, Intra-Aortic And Control, 64); DQX (Wire, Guide, Catheter, 10); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 7).
Next steps
- See all 136 Datascope Corp. clearances with predicates and recalls
- Run predicate analysis for product code DSP, Datascope Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.