510(k) · Cleared
ClearedAcs Indeflator Plus (Modification #2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Cardiovascular Systems, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Oct 20, 1987 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Oct 20, 1987
- Review
- 81 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK872981 Acs Indeflator Plus (Modification #2)Advanced Cardiovascular Systems, Inc. · 1987
- Descendant · cites it directly · 9 of its ownK961471 Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the…Advanced Cardiovascular Systems, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 5 of its ownK042449 Dolphin Inflation DeviceSedat S.A. · 2005 · Recalled
- Descendant · 3 generations on · 3 of its ownK082755 Sedat FlamingoSedat · 2008 · Recalled
- 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
- Descendant · 4 generations on · 1 of its ownK152387 Fluent Inflation DeviceVascular Solutions, Inc. · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K961471Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115…Advanced Cardiovascular Systems, Inc. · 1996 · cites it directly9descendants
- K042449Dolphin Inflation DeviceSedat S.A. · 2005 · 2 generations on5descendants
- K082755Sedat FlamingoSedat · 2008 · 3 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 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | K042449 | Dolphin Inflation Device | Sedat S.A. | 2005 | 4 |
| +3 | K082755 | Sedat Flamingo | Sedat | 2008 | 1 |
| +1 | K962495 | Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating… | Advanced Cardiovascular Systems, Inc. | 1996 | 3 |
| +4 | K152387 | Fluent Inflation Device | Vascular Solutions, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXT? 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 DXT device
- #1 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K961471 (Advanced Cardiovascular Systems, Inc., 1996) has gone furthest, with 9 descendants of its own.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXT
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXT
10in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXT
97in 2025
MAUDE reports naming product code DXT, 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 | 3 | 182 | 4 | 107 |
| 2008 | 2 | — | 3 | 168 |
| 2009 | 6 | 137 | 7 | 188 |
| 2010 | 1 | — | 3 | 124 |
| 2011 | 4 | 69 | 3 | 133 |
| 2012 | 0 | — | 7 | 135 |
| 2013 | 2 | — | 0 | 141 |
| 2014 | 6 | 144 | 0 | 97 |
| 2015 | 7 | 153 | 1 | 135 |
| 2016 | 8 | 172 | 0 | 152 |
| 2017 | 7 | 183 | 0 | 128 |
| 2018 | 9 | 93 | 2 | 129 |
| 2019 | 4 | 96 | 0 | 121 |
| 2020 | 3 | 154 | 1 | 93 |
| 2021 | 1 | — | 1 | 132 |
| 2022 | 0 | — | 0 | 111 |
| 2023 | 1 | — | 2 | 117 |
| 2024 | 4 | 138 | 10 | 118 |
| 2025 | 1 | — | 0 | 97 |
| 2026 | 7 | 264 | 6 | — |
https://510kreport.com/device/K872981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K872981: Acs Indeflator Plus (Modification #2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872981
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026