510(k) · Cleared
Recalled · Class II · 2022Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Cardiovascular Systems, Inc. · MAV Syringe, Balloon Inflation
Cleared on Sep 12, 1996 as substantially equivalent to K872981 (Advanced Cardiovascular Systems, Inc., 1987) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1987. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 12, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- MAV
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K872981 (1987). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK872981 Acs Indeflator Plus (Modification #2)Advanced Cardiovascular Systems, Inc. · 1987
- 1 generation backK961471 Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the…Advanced Cardiovascular Systems, Inc. · 1996 · Recalled
- This deviceK962495 Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115…Advanced Cardiovascular Systems, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK102648 Ant Inflation Device/Ant Inflation Device Compact PackShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK133795 Summed Inflation Device KitSunny Medical Device (Shenzhen) Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK122152 Oxti Inflation DeviceOxti Corporation · 2012
Most influential descendants
Showing 3 of 3 · See all- K102648Ant Inflation Device/Ant Inflation Device Compact PackShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2011 · cites it directly1descendant
- K133795Summed Inflation Device KitSunny Medical Device (Shenzhen) Co., Ltd. · 2014 · 2 generations on0descendants
- K122152Oxti Inflation DeviceOxti Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872981 | Acs Indeflator Plus (Modification #2) | Advanced Cardiovascular Systems, Inc. | 1987 | — |
| −1 | K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or… | Advanced Cardiovascular Systems, Inc. | 1996 | 7 |
| 0 (this device) | K962495 | Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating… | Advanced Cardiovascular Systems, Inc. | 1996 | — |
| +1 | K102648 | Ant Inflation Device/Ant Inflation Device Compact Pack | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2011 | — |
| +2 | K133795 | Summed Inflation Device Kit | Sunny Medical Device (Shenzhen) Co., Ltd. | 2014 | — |
| +1 | K122152 | Oxti Inflation Device | Oxti Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
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 K260035 Digital Indeflator INFLANTEscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K872981 | Acs Indeflator Plus (Modification #2)Summary page 1…e and PLUS 30 PRIORITY PACK™ Device Name: INDEFLATOR PLUS 30™ Inflation Device PLUS 30 PRIORITY PACK™ Devices to which Equivalence is Claimed: ACS INDEFLATOR PLUS 20™ (K872981, October 20, 1987) and the ACS 20/30 INDEFLATOR™ (K961471, May 8, 1996). Indication for Use: The INDEFLATOR PLUS 30™ Inflation D… | 1987 |
| * | K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115…Summary page 1…30™ Inflation Device PLUS 30 PRIORITY PACK™ Devices to which Equivalence is Claimed: ACS INDEFLATOR PLUS 20™ (K872981, October 20, 1987) and the ACS 20/30 INDEFLATOR™ (K961471, May 8, 1996). Indication for Use: The INDEFLATOR PLUS 30™ Inflation Device is recommended for use during vascular procedures in… | 1996 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2022 | Class II | Z-0925-2022 | Component change control | Due to an increase in complaint trend for leaks and intermittent/loose connections. |
| Mar 11, 2022 | Class II | Z-0924-2022 | Component change control | Due to an increase in complaint trend for leaks and intermittent/loose connections. |
| Jul 3, 2018 | Class II | Z-0960-2019 | Incorrect or no expiration date | Incorrect expiration being entered for one lot. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 8.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K102648 (Shenzhen Ant Hi-Tech Industrial Co., Ltd., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K872981.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MAV
69in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAV
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAV
66in 2025
MAUDE reports naming product code MAV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 37 |
| 2008 | 1 | — | 0 | 50 |
| 2009 | 0 | — | 0 | 99 |
| 2010 | 0 | — | 3 | 88 |
| 2011 | 1 | — | 0 | 94 |
| 2012 | 4 | 85 | 0 | 251 |
| 2013 | 1 | — | 0 | 245 |
| 2014 | 2 | — | 2 | 92 |
| 2015 | 3 | 116 | 0 | 121 |
| 2016 | 3 | 69 | 1 | 124 |
| 2017 | 0 | — | 0 | 246 |
| 2018 | 0 | — | 1 | 300 |
| 2019 | 0 | — | 0 | 199 |
| 2020 | 0 | — | 0 | 101 |
| 2021 | 0 | — | 0 | 186 |
| 2022 | 1 | — | 5 | 437 |
| 2023 | 0 | — | 0 | 220 |
| 2024 | 0 | — | 4 | 420 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The INDEFLATOR PLUS 30™ Inflation Device is recommended for use during vascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.
The PLUS 30 PRIORITY PACK™ Accessory Kit is recommended for use during vascular 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.
https://510kreport.com/device/K962495 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962495: Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962495
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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