# Datascope Corp.

- Location (FDA's records): Oakland, NJ
- FDA decisions: 137 (1976–2019): 136 510(k) clearances and 1 original PMA approval
- Product codes: DSP (64), DQX (10), DRT (7), DYB (5), MHX (4), DXN (4), DSI (3), MWI (3), CCK (3), DQA (2), LDD (2), CBQ (2)
- 510(k) review time since 2016: median 73 days, against 73 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 109 (63 its own); citations of its devices by later devices: 98 (63 its own)
- Recalls linked to its devices: 93 (39 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arrow Intl., Inc.: 13 (https://510kreport.com/company/arrow-intl)
- Spacelabs Medical, Inc.: 4 (https://510kreport.com/company/spacelabs-medical)
- Welch Allyn Protocol, Inc.: 3 (https://510kreport.com/company/welch-allyn-protocol)
- Boston Scientific Corp: 3 (https://510kreport.com/company/boston-scientific)
- Cardiac Assist, Maquet Cardiovascular, LLC: 3 (https://510kreport.com/company/cardiac-assist-maquet-cardiovascular)
- Marquette Electronics, Inc.: 3 (https://510kreport.com/company/marquette-electronics)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- General Electric Medical Systems Information Techn: 1 (https://510kreport.com/company/general-electric-medical-systems-information-techn)

## Firms that cite its devices most
- Datascope Corp., Cardiac Assist Division: 5 (https://510kreport.com/company/datascope-cardiac-assist-division)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 4 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Datascope Corp., Patient Monitoring Division: 2 (https://510kreport.com/company/datascope-patient-monitoring-division)
- Mindray DS USA, Inc.: 2 (https://510kreport.com/company/mindray-ds-usa)
- Arrow Intl., Inc.: 2 (https://510kreport.com/company/arrow-intl)
- Cardiac Assist, Maquet Cardiovascular, LLC: 2 (https://510kreport.com/company/cardiac-assist-maquet-cardiovascular)
- Abiomed, Inc.: 2 (https://510kreport.com/company/abiomed)
- Cordis Neurovascular, Inc.: 1 (https://510kreport.com/company/cordis-neurovascular)

## Its most-cited devices
- K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX (2002), cited by 5
- K013326: Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B (2001), cited by 5
- K940178: Percor Stat-DL 9.5 FR.34CC & 40CC /Percor Stat-DL 10.5 FR.40CC & 50CC Intra-Aortic Balloon Modification (1994), cited by 5
- K940231: Intra-Aortic Balloon for Optional Sheathless Insertion (1994), cited by 4
- K964987: Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0 (1997), cited by 4
- K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX (2000), cited by 4

## Recent decisions
- K190884: TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool (Dec 26, 2019)
- K181122: CARDIOSAVE Intra-Aortic Balloon Pump (May 31, 2018)
- K172305: CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (Oct 12, 2017)
- K163542: CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case (Jan 31, 2017)
- K151254: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (Jul 2, 2015)
- K133074: Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and Accessories (Dec 12, 2013)
- K071805: Netguard Automated Clinician Alert System, Model 0998-00-1600-XX (Sep 25, 2007)
- K062569: Safeguard 24 CM Pressure Assisted Dressing (Feb 14, 2007)

Source page: https://510kreport.com/company/datascope