510(k) Report

510(k) · Cleared

Cleared

Datascope Percor Stat DL 10.5 FR 50CC

K903930510(k) TraditionalCleared Nov 16, 199084-day reviewClass II21 CFR 870.3535

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Datascope Corp. · DSP System, Balloon, Intra-Aortic And Control

Cleared on Nov 16, 1990 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Nov 16, 1990
Review
84 days
Class
Class II
Product code
DSP
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK903930 Datascope Percor Stat DL 10.5 FR 50CCDatascope Corp. · 1990
  2. Descendant · cites it directly · 3 of its ownK091449 Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories…Datascope Corp., Cardiac Assist Division · 2009
  3. Descendant · 2 generations on · 2 of its ownK112327 Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and…Cardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK133074 Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon…Datascope Corp. · 2013 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK122628 Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and…Datascope Corp., Cardiac Assist Division · 2012 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Datascope Corp., Cardiac Assist Division · 2009 · cites it directly3descendants
  • K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on2descendants
  • K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp. · 2013 · 2 generations on0descendants
  • K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division · 2012 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903930Datascope Percor Stat DL 10.5 FR 50CCDatascope Corp.1990—
+1K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Datascope Corp., Cardiac Assist Division2009—
+2K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC20111
+2K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and…Datascope Corp.20139
+3K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division20123

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201210
201310
FIG. 1 — Lineage of K903930, 1990–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DSP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DSP device

  1. #1 K250542 AC3™ Range™ Intra-Aortic Balloon Pumpscore 11.2 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Datascope Corp., Cardiac Assist Division20093

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K091449 (Datascope Corp., Cardiac Assist Division, 2009) has gone furthest, with 3 descendants of its own.

How does its category compare?

All DSP devices

DSP System, Balloon, Intra-Aortic And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSP

1in 2025

2007: 22009: 22011: 22012: 22013: 12015: 12017: 32018: 12019: 32020: 22023: 12025: 1
2007high 3 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSP

140in 2019

2017: 73 days median2019: 140 days median
2007high 140 (2019) · low 73 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSP

4in 2025

2007: 32009: 142010: 82012: 32014: 12016: 9, 9 Class I2018: 2, 2 Class I2019: 32021: 5, 3 Class I2022: 33, 33 Class I2024: 12025: 4
2007high 33 (2022) · low 0 (2008)2026

Class I (47 since 2007) Class II/III not classified

Adverse event reports per year · DSP

7,422in 2025

2007: 4612008: 6172009: 6562010: 1,0192011: 5902012: 4902013: 4952014: 1,7382015: 4042016: 4192017: 2,1642018: 3,3312019: 3,5522020: 3,3932021: 4,3452022: 5,1132023: 6,9802024: 7,3172025: 7,422
2007high 7,422 (2025) · low 404 (2015)2025

MAUDE reports naming product code DSP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—3461
20080—0617
20092—14656
20100—81,019
20112—0590
20122—3490
20131—0495
20140—11,738
20151—0404
20160—9 (9)419
201737302,164
20181—2 (2)3,331
2019314033,552
20202—03,393
20210—5 (3)4,345
20220—33 (33)5,113
20231—06,980
20240—17,317
20251—47,422
20260—0—

More from Datascope Corp.

149 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in DSP

The DSP category page

  • K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLC · 2025
  • K232343AC3™ Series IABPArrow International, LLC · 2023
  • K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 202011 Class I recalls
  • K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc. · 20201 Class I recall
  • K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex · 2019

https://510kreport.com/device/K903930 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903930: Datascope Percor Stat DL 10.5 FR 50CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903930

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026