510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump

K172305510(k) SpecialCleared Oct 12, 201773-day reviewClass II21 CFR 870.3535Recalls 2

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 Oct 12, 2017 as substantially equivalent to K031636 (Datascope Corp., 2003) and 1 other predicate after a 73-day review. Its family tree reaches back 9 generations to 1990. 8 of the 64 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times.

Decided
Oct 12, 2017
Review
73 days
Class
Class II
Product code
DSP
Recalls
2
Predicates
2

Its longest line of descent runs back 9 generations to K892222 (1990). 63 ancestors in all, the oldest K790775 (1979). No later device cites it as a predicate yet. 8 of the 64 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2003: 1 other ancestor, 1 with a Class I recall12006: 1 other ancestor, 1 with a Class I recall12004: 1 other ancestor2002: 1 other ancestor, 1 with a Class I recall12000: 5 other ancestors, 2 with a Class I recall21998: 4 other ancestors, 1 with a Class I recall11997: 6 other ancestors, 1 with a Class I recall12001: 1 other ancestor1995: 9 other ancestors1996: 8 other ancestors1992: 1 other ancestor1991: 4 other ancestors1989: 1 other ancestor1994: 3 other ancestors1993: 4 other ancestors1990: 2 other ancestors1982: 1 other ancestor1979: 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. · 2001K031569 · Datascope CA 40 8FR. Iabs, Model 0684-00-04XX · Datascope Corp. · 2003K041281 · Datascope 7.5FR. Iab Catheter and Accessories · Datascope Corp. · 2004 · recalledK063525 · Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System · Datascope Corp. · 2007 · Class I recall1980199020002010
Other ancestors, by generation 1 generation back: 1 other ancestor, 1 with a Class I recall12 generations back: 6 other ancestors, 4 with a Class I recall43 generations back: 9 other ancestors, 2 with a Class I recall24 generations back: 7 other ancestors5 generations back: 23 other ancestors6 generations back: 8 other ancestors K063525 · Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System · Datascope Corp. · 2007 · Class I recallK041281 · Datascope 7.5FR. Iab Catheter and Accessories · Datascope Corp. · 2004 · recalledK031569 · Datascope CA 40 8FR. Iabs, Model 0684-00-04XX · Datascope Corp. · 2003K013326 · 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 · 9 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
  2. 5 generations between
  3. 3 generations backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
  4. 2 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
  5. 1 generation backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
  6. This deviceK172305 CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon…Datascope Corp. · 2017
Show all 9 generations
  1. Root · 9 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
  2. 8 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
  3. 7 generations backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
  4. 6 generations backK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
  5. 5 generations backK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
  6. 4 generations backK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
  7. 3 generations backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
  8. 2 generations backK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
  9. 1 generation backK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
  10. This deviceK172305 CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon…Datascope Corp. · 2017

Class I recalls in this family

  • K063525 Datascope Fiber Optic Pressure Sensor…direct predicate · 2007
  • K031636 CS100 Intra-Aortic Balloon Pump, Model…direct predicate · 2003
  • K060309 Autocat Intra-Aortic Balloon Pump Series2 generations back · 2006
  • K021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a…2 generations back · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K8922229.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc.1990—
−8K963187Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930…Boston Scientific Corp1996—
−7K97211330 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp1997—
−6K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for…Datascope Corp.1998—
−5K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models…Datascope Corp.2000—
−4K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC…Datascope Corp.2001—
−3K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp.2003—
−2K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp.20047
−1K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp.2007Class I
0 (this device)K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
198910
199020
199140
199210
199340
199430
199590
199680
199761
199841
200052
200110
200211
200311
200410
200611
FIG. 1 — Lineage of K172305, 1990–2017Source: 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.

8 devices in this family have 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? (2)

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
*K031636CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX
Summary page 4
…870.3535 Regulatory Class: Class II Product Code: DSP PREDICATE DEVICE INFORMATION: CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (K031636 and K063525) DEVICE DESCRIPTION: The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) are cardiac assist devices. The…
Datascope Corp.2003Class I
*K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…
Summary page 4
…gulatory Class: Class II Product Code: DSP PREDICATE DEVICE INFORMATION: CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (K031636 and K063525) DEVICE DESCRIPTION: The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) are cardiac assist devices. The IABP support…
Datascope Corp.2007Class I

Also cleared against K031636: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (8 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 23, 2026Class IIZ-1486-2026Under Investigation by firmThe firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Jan 23, 2026Class IIZ-1487-2026Under Investigation by firmThe firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

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.

  • K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
  • K031636CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDatascope Corp. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 15 Class I recalls
  • K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 128 Class I recalls
  • K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models…Arrow Intl., Inc. · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
  • K981660Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersC.R. Bard, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 12 Class I recalls
  • K965236System 96 Intra-Aortic Balloon Pump (Iabp)Datascope Corp. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
  • K000729Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC UniversalArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 17 Class I recalls
  • K9939668FR. Narrowflex Universal Intra-Aortic Balloon CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall

Nearest 5 of 8; all are on the web page.

What does this lineage say?

  • The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 15 of the 63 ancestors have a recall of any class; 8 have a Class I recall.
  • 2 other devices also cite its predicate K031636.

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. 2017, this device’s year, is highlighted.

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?

The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

Indications for use as stated in the FDA summary.

Also cleared against K031636

2 other devices cite the same predicate.

  • K070225Supracor Intr-Aortic Balloon Pump ConsoleAbiomed, Inc. · 2007
  • K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 20071 Class I recall

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
  • 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

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/K172305 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172305: CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172305

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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