510(k) Report

510(k) · Decided

Recalled · Class II · 2024

Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115 Rotating Hemostatic Valve)

K961471510(k) TraditionalDecided May 8, 199621-day reviewClass II21 CFR 870.1650Recalls 7

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

Advanced Cardiovascular Systems, Inc. · MAV Syringe, Balloon Inflation

Cleared on May 8, 1996 as substantially equivalent to K872981 (Advanced Cardiovascular Systems, Inc., 1987) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1987. 9 later devices descend from it. It has been recalled 7 times.

Decided
May 8, 1996
Review
21 days
Class
Class II
Product code
MAV
Recalls
7
Predicates
2

Its longest line of descent runs back 1 generation to K872981 (1987). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1989: 1 other ancestor2005: 1 descendant cleared1996: 1 descendant cleared2008: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant clearedK872981 · Acs Indeflator Plus (Modification #2) · Advanced Cardiovascular Systems, Inc. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K872981 · Acs Indeflator Plus (Modification #2) · Advanced Cardiovascular Systems, Inc. · 19870
  1. Root · 1 generation backK872981 Acs Indeflator Plus (Modification #2)Advanced Cardiovascular Systems, Inc. · 1987
  2. This deviceK961471 Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the…Advanced Cardiovascular Systems, Inc. · 1996
  3. Descendant · cites it directly · 5 of its ownK042449 Dolphin Inflation DeviceSedat S.A. · 2005 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK082755 Sedat FlamingoSedat · 2008 · Recalled
  5. Descendant · cites it directly · 3 of its ownK962495 Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115…Advanced Cardiovascular Systems, Inc. · 1996 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK152387 Fluent Inflation DeviceVascular Solutions, Inc. · 2015
  7. Descendant · 2 generations on · 1 of its ownK102648 Ant Inflation Device/Ant Inflation Device Compact PackShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2011

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

1996: 12005: 12008: 12011: 12012: 12013: 12014: 12015: 12016: 1
1996high 1 (1996) · low 0 (1997)2026

Most influential descendants

Showing 5 of 9 · See all
  • K042449Dolphin Inflation DeviceSedat S.A. · 2005 · cites it directly5descendants
  • K082755Sedat FlamingoSedat · 2008 · 2 generations on3descendants
  • K962495Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve)Advanced Cardiovascular Systems, Inc. · 1996 · cites it directly3descendants
  • K152387Fluent Inflation DeviceVascular Solutions, Inc. · 2015 · 3 generations on1descendant
  • K102648Ant Inflation Device/Ant Inflation Device Compact PackShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2011 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K872981Acs Indeflator Plus (Modification #2)Advanced Cardiovascular Systems, Inc.1987—
0 (this device)K961471Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or…Advanced Cardiovascular Systems, Inc.1996—
+1K042449Dolphin Inflation DeviceSedat S.A.20054
+2K082755Sedat FlamingoSedat20081
+1K962495Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating…Advanced Cardiovascular Systems, Inc.19963
+3K152387Fluent Inflation DeviceVascular Solutions, Inc.2015—
+2K102648Ant Inflation Device/Ant Inflation Device Compact PackShenzhen Ant Hi-Tech Industrial Co., Ltd.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200510
200810
201110
201210
201310
201410
201510
201610
FIG. 1 — Lineage of K961471, 1987–2016Source: 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.

Planning a device in MAV? 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 MAV device

  1. #1 K260035 Digital Indeflator INFLANTEscore 12.6 · 3 generations · no Class I recall
  2. #2 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
*K872981Acs Indeflator Plus (Modification #2)
Summary page 1
…20/36 PRIORITY PACK™ Device Name: INDEFLATOR 20/30™ Inflation Device 20/30 PRIORITY PACK™ Accessory Kit Devices to which Equivalence is Claimed: ACS INDEFLATOR 20/20™ (K872981, October 20, 1987 and Baxter Inflation Pro™ II inflation device (K895836, December 20, 1989). ' Indication for Use: INDEFLATOR…
Advanced Cardiovascular Systems, Inc.1987—
*K895836Inflation Pro II
Summary page 1
…30 PRIORITY PACK™ Accessory Kit Devices to which Equivalence is Claimed: ACS INDEFLATOR 20/20™ (K872981, October 20, 1987 and Baxter Inflation Pro™ II inflation device (K895836, December 20, 1989). ' Indication for Use: INDEFLATOR 20/30™ Infiation Device- The INDEFLATOR 20/30™ Inflation Device is recomm…
Baxter Healthcare Corp1989—

Also cleared against K872981: 1 other device →

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042449Dolphin Inflation DeviceSedat S.A.20055
K962495Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve)Advanced Cardiovascular Systems, Inc.19963

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 6, 2024Class IIZ-0730-2025Component change controlInflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Nov 6, 2024Class IIZ-0731-2025Component change controlInflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Nov 6, 2024Class IIZ-0732-2025Component change controlInflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Nov 6, 2024Class IIZ-0733-2025Component change controlInflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Mar 11, 2022Class IIZ-0922-2022Component change controlDue to an increase in complaint trend for leaks and intermittent/loose connections.
Mar 11, 2022Class IIZ-0923-2022Component change controlDue to an increase in complaint trend for leaks and intermittent/loose connections.
Mar 11, 2022Class IIZ-0921-2022Component change controlDue to an increase in complaint trend for leaks and intermittent/loose connections.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K042449 (Sedat S.A., 2005) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K872981.

How does its category compare?

All MAV devices

MAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAV

1in 2022

2008: 12011: 12012: 42013: 12014: 22015: 32016: 32022: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAV

69in 2016

2012: 85 days median2015: 116 days median2016: 69 days median
2007high 116 (2015) · low 69 (2016)2026

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

Recalls per year · MAV

4in 2024

2010: 32014: 22016: 12018: 12022: 52024: 4
2007high 5 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAV

66in 2025

2007: 372008: 502009: 992010: 882011: 942012: 2512013: 2452014: 922015: 1212016: 1242017: 2462018: 3002019: 1992020: 1012021: 1862022: 4372023: 2202024: 4202025: 66
2007high 437 (2022) · low 37 (2007)2025

MAUDE reports naming product code MAV, 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
20070—037
20081—050
20090—099
20100—388
20111—094
20124850251
20131—0245
20142—292
201531160121
20163691124
20170—0246
20180—1300
20190—0199
20200—0101
20210—0186
20221—5437
20230—0220
20240—4420
20250—066
20261—0—

What is it indicated for?

INDEFLATOR 20/30™ Inflation Device- The INDEFLATOR 20/30™ Inflation Device is recommended for use during cardiovascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.

20/30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during cardiovascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.)

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 K872981

1 other device cites the same predicate.

  • K962495Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve)Advanced Cardiovascular Systems, Inc. · 19963 recalls

More from Advanced Cardiovascular Systems, Inc.

325 FDA decisions under this applicant name. See the company

  • P810046/S240Coronary Dilatation CathetersAdvanced Cardiovascular Systems, Inc. · 2010
  • P810046/S237Voyager NC Coronary Dilatation CatheterAdvanced Cardiovascular Systems, Inc. · 2010
  • P810046/S238Voyager NC Coronary Dilatation CatheterAdvanced Cardiovascular Systems, Inc. · 2010
  • P810046/S236Simpson-Robert Coronary Balloon Dilatation Catheters Voyager/Voyager NCAdvanced Cardiovascular Systems, Inc. · 2010
  • P810046/S234Voyager NC Coronary Dilatation CatheterAdvanced Cardiovascular Systems, Inc. · 2010

Recent decisions in MAV

The MAV category page

  • K260035Digital Indeflator INFLANTEUAB Telemedicina · 2026
  • K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock…Medtronic Vascular · 2022
  • K162272Fluent inflation deviceVascular Solutions, Inc. · 2016
  • K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device…Medtronic, Inc. · 2016
  • K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc. · 2016

https://510kreport.com/device/K961471 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961471: Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115 Rotating Hemostatic Valve).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961471

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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