510(k) · Cleared
ClearedAnt Inflation Device/Ant Inflation Device Compact Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Ant Hi-Tech Industrial Co., Ltd. · MAV Syringe, Balloon Inflation
Cleared on Jul 1, 2011 as substantially equivalent to K962495 (Advanced Cardiovascular Systems, Inc., 1996) after a 290-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it.
- Decided
- Jul 1, 2011
- Review
- 290 days
- Class
- Class II
- Product code
- MAV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K872981 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK872981 Acs Indeflator Plus (Modification #2)Advanced Cardiovascular Systems, Inc. · 1987
- 2 generations backK961471 Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the…Advanced Cardiovascular Systems, Inc. · 1996 · Recalled
- 1 generation backK962495 Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115…Advanced Cardiovascular Systems, Inc. · 1996 · Recalled
- This deviceK102648 Ant Inflation Device/Ant Inflation Device Compact PackShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK133795 Summed Inflation Device KitSunny Medical Device (Shenzhen) Co., Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133795Summed Inflation Device KitSunny Medical Device (Shenzhen) Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872981 | Acs Indeflator Plus (Modification #2) | Advanced Cardiovascular Systems, Inc. | 1987 | — |
| −2 | K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or… | Advanced Cardiovascular Systems, Inc. | 1996 | 7 |
| −1 | K962495 | Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating… | Advanced Cardiovascular Systems, Inc. | 1996 | 3 |
| 0 (this device) | K102648 | Ant Inflation Device/Ant Inflation Device Compact Pack | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2011 | — |
| +1 | K133795 | Summed Inflation Device Kit | Sunny Medical Device (Shenzhen) Co., Ltd. | 2014 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K962495 | Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve)Summary page 1…ce Class: 11 Regulation Number: 870-1650 Device Code: MAV Predicate Device: INDIEFLATIOR PLUS 30 Inflation Device and PLUS 30 PRIORITY PACK as cleared in K962495. Intended Use: The ANT Inflation Device is intended for use during vascular procedures in conjunction with interventional device… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133795 | Summed Inflation Device Kit | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K133795 (Sunny Medical Device (Shenzhen) Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K962495.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 ANT Inflation Device is intended for use during vascular procedures in conjunction with interventional device such as balloon catheters to create and monitor pressure in the balloon catheter.
The ANT Inflation Device Compact Pack:
-ANT Inflation Device: See description above.
-ANT Inflation Device Accessory Kit: The Accessory Kit is recommended for use
during vascular procedures in conjunction and/or diagnostic device (e.g., balloon
dilatation catheters, adtherectomy devices, sent delivery systems, intravascular
urtrasound devices.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102648: Ant Inflation Device/Ant Inflation Device Compact Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102648
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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