510(k) · Cleared
ClearedSummed Inflation Device Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunny Medical Device (Shenzhen) Co., Ltd. · MAV Syringe, Balloon Inflation
Cleared on Dec 12, 2014 as substantially equivalent to K102648 (Shenzhen Ant Hi-Tech Industrial Co., Ltd., 2011) and 1 other predicate after a 364-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Dec 12, 2014
- Review
- 364 days
- Class
- Class II
- Product code
- MAV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953522 (1996). 10 ancestors in all, the oldest K872981 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- 3 generations backK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- 2 generations backK972964 Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997
- 1 generation backK032840 Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004
- This deviceK133795 Summed Inflation Device KitSunny Medical Device (Shenzhen) Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| −3 | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| −2 | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| −1 | K032840 | Atrion Medical QL Inflation Device | Atrion Medical Products, Inc. | 2004 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K102648 | Ant Inflation Device/Ant Inflation Device Compact PackSummary page 4…Manufacture Number Name ANT Inflation Device/ ANT Shenzhen ANT Hi-Tech K102648 Inflation Device Compact Pack Industrial Co., Ltd. Atrion Medical QL® Inflation… | 2011 |
| * | K032840 | Atrion Medical QL Inflation DeviceSummary page 4…Shenzhen ANT Hi-Tech K102648 Inflation Device Compact Pack Industrial Co., Ltd. Atrion Medical QL® Inflation K032840 Atrion Medical Products, Inc. Device 4. Device description… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 10 ancestors have a recall of any class.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 SunmedTM Inflation Device is a set of accessorial device. It is composed of an
inflation device, and may be composed of a stopcock and a hemostatic valve. The
inflation device is intended for use in PTCA or PTA procedures to create and monitor
pressure (by connecting the rotating male luer of inflation device with the balloon
catheter's female luer) in the balloon and to deflate the balloon. The hemostatic valve is
recommended for use during PTCA or PTA procedures in conjunction and/or diagnostic
device (e.g. balloon dilatation catheters).Stopcock is used to release and purge any
trapped air (if used).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133795: Summed Inflation Device Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133795
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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