510(k) Report

510(k) · Cleared

Cleared

Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True Sheathless DL 9.5 FR. Iab; Datascope's

K020257510(k) TraditionalCleared Apr 24, 200290-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 Apr 24, 2002 as substantially equivalent to K013326 (Datascope Corp., 2001) and 5 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1990. 1 of the 51 devices in its family, counting itself, has a Class I recall.

Decided
Apr 24, 2002
Review
90 days
Class
Class II
Product code
DSP
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K892222 (1990). 50 ancestors in all, the oldest K790775 (1979). No later device cites it as a predicate yet. 1 of the 51 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2001: 1 other ancestor2000: 2 other ancestors1998: 2 other ancestors1997: 5 other ancestors, 1 with a Class I recall11996: 8 other ancestors1995: 9 other ancestors1994: 3 other ancestors1993: 4 other ancestors1992: 1 other ancestor1991: 4 other ancestors1989: 1 other ancestor1979: 1 other ancestor1990: 2 other ancestors1982: 1 other ancestorK892222 · 9.5F Percu Double Lumen Intra-Aortic Balloon · Kontron Instruments, Inc. · 1990K963187 · Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30 - 40 CC Sensation and Nicath 30C · Boston Scientific Corp · 1996K972113 · 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel · Boston Scientific Corp · 1997K980385 · Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories · Datascope Corp. · 1998K994157 · Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 · Datascope Corp. · 2000K013326 · Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B · Datascope Corp. · 2001197519801985199019952000
Other ancestors, by generation 1 generation back: 5 other ancestors, 1 with a Class I recall12 generations back: 21 other ancestors4 generations back: 13 other ancestors5 generations back: 5 other ancestors K013326 · Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B · Datascope Corp. · 2001K994157 · Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 · Datascope Corp. · 2000K980385 · Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories · Datascope Corp. · 1998K972113 · 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel · Boston Scientific Corp · 1997K963187 · Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30 - 40 CC Sensation and Nicath 30C · Boston Scientific Corp · 1996K892222 · 9.5F Percu Double Lumen Intra-Aortic Balloon · Kontron Instruments, Inc. · 1990−50
  1. Root · 6 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
  2. 5 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
  3. 4 generations backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
  4. 3 generations backK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
  5. 2 generations backK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
  6. 1 generation backK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
  7. This deviceK020257 Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab…Datascope Corp. · 2002

Class I recalls in this family

  • K965236 System 96 Intra-Aortic Balloon Pump (Iabp)direct predicate · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K8922229.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc.1990—
−5K963187Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930…Boston Scientific Corp1996—
−4K97211330 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp1997—
−3K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for…Datascope Corp.1998—
−2K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models…Datascope Corp.2000—
−1K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC…Datascope Corp.2001—
0 (this device)K020257Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's…Datascope Corp.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
198910
199020
199140
199210
199340
199430
199590
199680
199751
199820
200020
200110
FIG. 1 — Lineage of K020257, 1990–2002Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…
Summary page 1
…74DSP C. PREDICATE DEVICE INFORMATION Datascope’s Intra-Aortic Balloon Catheters Indications for Use are substantially equivalent to the following marketed devices: KO013326 - Datascope 8Fr. 25, 34 & 40cc Alt B IAB K003598 - Datascope Profile 8Fr. 34 & 40cc Alt B IAB K980780 - Datascope Percor STAT-D…
Datascope Corp.2001—
*K003598Datascope Profile 8FR. Alt B Iab, 34CC, Datascope Profile 8FR. Alt B Iab, 40CC, Model…
Summary page 1
…’s Intra-Aortic Balloon Catheters Indications for Use are substantially equivalent to the following marketed devices: KO013326 - Datascope 8Fr. 25, 34 & 40cc Alt B IAB K003598 - Datascope Profile 8Fr. 34 & 40cc Alt B IAB K980780 - Datascope Percor STAT-DL 9.5Fr. 25, 34 & 40cc Alt B IAB K964987 - Percor…
Datascope Corp.2000—
*K980780Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B…
Summary page 1
…are substantially equivalent to the following marketed devices: KO013326 - Datascope 8Fr. 25, 34 & 40cc Alt B IAB K003598 - Datascope Profile 8Fr. 34 & 40cc Alt B IAB K980780 - Datascope Percor STAT-DL 9.5Fr. 25, 34 & 40cc Alt B IAB K964987 - Percor STAT-DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless…
Datascope Corp.1998—
*K964987Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional…
Summary page 1
…013326 - Datascope 8Fr. 25, 34 & 40cc Alt B IAB K003598 - Datascope Profile 8Fr. 34 & 40cc Alt B IAB K980780 - Datascope Percor STAT-DL 9.5Fr. 25, 34 & 40cc Alt B IAB K964987 - Percor STAT-DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless Insertion and Percor STAT-DL 10.5Fr. 40 & 50cc IABs for Sheath Ins…
Datascope Corp.19971
*K965236System 96 Intra-Aortic Balloon Pump (Iabp)
Summary page 1
…25, 34 & 40cc Alt B IAB K964987 - Percor STAT-DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless Insertion and Percor STAT-DL 10.5Fr. 40 & 50cc IABs for Sheath Insertion K965236 - Datascope System 96 Intra-Aortic Balloon Pump K002256 - Arrow ACAT 2 Intra-Aortic Balloon Pump All of the above referenced pr…
Datascope Corp.1997Class I
*K002256Arrow Acat 2 Intra-Aortic Balloon Pump
Summary page 1
…25 & 40cc IABs for Optional Sheathless Insertion and Percor STAT-DL 10.5Fr. 40 & 50cc IABs for Sheath Insertion K965236 - Datascope System 96 Intra-Aortic Balloon Pump K002256 - Arrow ACAT 2 Intra-Aortic Balloon Pump All of the above referenced premarket notifications were found substantially equivalent…
Arrow Intl., Inc.2001—

Also cleared against K013326: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K965236System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 5 of the 50 ancestors have a recall of any class; 1 has a Class I recall.
  • 4 other devices also cite its predicate K013326.

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—

What is it indicated for?

Intra-Aortic Balloon Catheter System to be used for the following: Refractory unstable angina Impending infarction Acute MI Refractory ventricular failure Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) Cardiogenic shock Support for diagnostic, percutaneous revascularization, and interventional procedures. Ischemia related intractable ventricular arrhythmias Septic shock Intraoperative pulsatile flow generation Weaning from…

Read the full statement (91 words)

Intra-Aortic Balloon Catheter System to be used for the following:

Refractory unstable angina

Impending infarction

Acute MI

Refractory ventricular failure

Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture)

Cardiogenic shock

Support for diagnostic, percutaneous revascularization, and interventional procedures.

Ischemia related intractable ventricular arrhythmias

Septic shock

Intraoperative pulsatile flow generation

Weaning from bypass

Cardiac support for non-cardiac surgery

Prophylactic support in preparation for cardiac surgery

Post surgical myocardial dysfunction/low cardiac output syndrome

Myocardial contusion

Mechanical bridge to other assist devices

Cardiac support following correction of anatomical defects

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K013326

4 other devices cite the same predicate.

  • K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02Datascope Corp., Cardiac Assist Division · 2009
  • K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 20071 Class I recall
  • K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 20047 recalls
  • K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003

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/K020257 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020257: Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True Sheathless DL 9.5 FR. Iab; Datascope's.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020257

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026