510(k) · Cleared
Recalled · 2008Reprocessed Baloon Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NKU Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
Cleared on May 4, 2006 as substantially equivalent to K955869 (Scimed Life Systems, Inc., 1996) after a 170-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.
- Decided
- May 4, 2006
- Review
- 170 days
- Class
- Class II
- Product code
- NKU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955869 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955869 Scimed Encore 26 Inflation Device/Encore 30 Inflation DeviceScimed Life Systems, Inc. · 1996 · Recalled
- This deviceK053188 Reprocessed Baloon Inflation DeviceSterilmed, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955869 | Scimed Encore 26 Inflation Device/Encore 30 Inflation Device | Scimed Life Systems, Inc. | 1996 | 1 |
| 0 (this device) | K053188 | Reprocessed Baloon Inflation Device | Sterilmed, Inc. | 2006 | — |
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 NKU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K955869 | Scimed Encore 26 Inflation Device/Encore 30 Inflation DeviceSummary page 1…substantially equivalent to the Encore 26 Inflation Device manufactured by Boston Scientific (K955869 cleared March 22, 1996) Device Description: The Reprocessed Balloon… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0546-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K955869.
How does its category compare?
All NKU devicesNKU Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKU
FDA has decided no NKU device since 2007.
Median 510(k) review, days · NKU
Too few NKU 510(k)s in any year since 2007 to give a median.
Recalls per year · NKU
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKU
No MAUDE report names NKU since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The reprocessed Balloon Inflation Device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053188: Reprocessed Baloon Inflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053188
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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