# K961471: Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115 Rotating Hemostatic Valve)

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: May 8, 1996 after 21 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K872981 (1987). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872981: Acs Indeflator Plus (Modification #2), Advanced Cardiovascular Systems, Inc. (1987) Summary page 1.
- K895836: Inflation Pro II, Baxter Healthcare Corp (1989) Summary page 1.

## Most influential descendants
- K042449: Dolphin Inflation Device (2005), 5 descendants of its own
- K082755: Sedat Flamingo (2008), 3 descendants of its own
- K962495: Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve) (1996), 3 descendants of its own
- K152387: Fluent Inflation Device (2015), 1 descendant of its own
- K102648: Ant Inflation Device/Ant Inflation Device Compact Pack (2011), 1 descendant of its own

## Recalls of this device
- Nov 6, 2024 · Class II · Z-0730-2025: Inflation 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, 2024 · Class II · Z-0731-2025: Inflation 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, 2024 · Class II · Z-0732-2025: Inflation 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, 2024 · Class II · Z-0733-2025: Inflation 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, 2022 · Class II · Z-0922-2022: Due to an increase in complaint trend for leaks and intermittent/loose connections.
- Mar 11, 2022 · Class II · Z-0923-2022: Due to an increase in complaint trend for leaks and intermittent/loose connections.
- Mar 11, 2022 · Class II · Z-0921-2022: Due to an increase in complaint trend for leaks and intermittent/loose connections.

## Indications for use
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.)

Source page: https://510kreport.com/device/K961471
Methodology: https://510kreport.com/methodology