510(k) Report

FDA applicant

Datascope Corp.

Oakland, NJ137 decisions1976–201993 recalls

FDA records 137 decisions for Datascope Corp. (Oakland, NJ) from 1976 to 2019: 136 510(k) clearances and 1 original PMA approval. Most are in product codes DSP (System, Balloon, Intra-Aortic And Control) and DQX (Wire, Guide, Catheter). Since 2016 its 510(k)s took a median of 73 days from receipt to decision, against 73 for FDA’s reviews in the same codes and years. Its devices cite 109 predicates, 63 of them its own earlier devices. 93 recalls are linked to its devices, 39 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Datascope Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007: 42013: 12015: 12017: 22018: 12019: 1
2007high 4 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2026

2007: 12009: 22010: 22011: 12014: 4, 1 Class I2016: 12017: 8, 6 Class I2018: 4, 3 Class I2019: 6, 6 Class I2020: 62021: 9, 3 Class I2022: 6, 2 Class I2023: 23, 14 Class I2024: 5, 4 Class I2025: 42026 (partial year): 2
2007high 23 (2023) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Datascope Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Datascope Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DSPSystem, Balloon, Intra-Aortic And Control64decisions
  • DQXWire, Guide, Catheter10decisions
  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)7decisions
  • DYBIntroducer, Catheter5decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)4decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive4decisions

Also: DSI (3), MWI (3), CCK (3), DQA (2), LDD (2), CBQ (2).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 73 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 73 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 109 predicates; 63 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 98 times; 63 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 20025cite it
  • K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR…Datascope Corp. · 20015cite it
  • K940178Percor Stat-DL 9.5 FR.34CC & 40CC /Percor Stat-DL 10.5 FR.40CC & 50CC Intra-Aortic Balloon ModificationDatascope Corp. · 19945cite it
  • K940231Intra-Aortic Balloon for Optional Sheathless InsertionDatascope Corp. · 19944cite it
  • K964987Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and…Datascope Corp. · 19974cite it
  • K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 20004cite it

What has FDA decided for it lately?

  • K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp. · 2019
  • K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 201827 Class I recalls
  • K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp. · 20172 recalls
  • K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 20177 Class I recalls
  • K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 201512 Class I recalls
  • K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp. · 20139 recalls
  • K071805Netguard Automated Clinician Alert System, Model 0998-00-1600-XXDatascope Corp. · 2007
  • K062569Safeguard 24 CM Pressure Assisted DressingDatascope Corp. · 2007

All 137 as Datascope Corp. →

What has been recalled?

93 recalls linked to its devices; the latest:

  • K172305CS100 IABP. Software Version CS100 IABP Q.01.Jan 23, 2026Class II
  • K172305CS300 IABP. Software Version CS300 IABP C.01.Jan 23, 2026Class II
  • K112372Cardiosave Hybrid. Intra-Aortic Balloon Pump system.Nov 4, 2025Class II
  • K163542Cardiosave Rescue. Intra-Aortic Balloon Pump system.Nov 4, 2025Class II
  • K112372Cardiosave RescueOct 23, 2025Class III
  • K112372Cardiosave HybridOct 23, 2025Class III

Other applicant names beginning “Datascope”

FDA records each applicant name separately; these may or may not be the same firm.

Datascope Corp., Patient Monitoring Division 4Datascope Corp., Cardiac Assist Division 4