510(k) · Cleared
ClearedAdvance Salivary Balloon Catheter with Wire Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 15, 2014 as substantially equivalent to K072749 (Sialo Technology, Ltd., 2008) and 2 other predicates after a 283-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Dec 15, 2014
- Review
- 283 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970041 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970041 | Ascend Balloon Dailation Catheter | Cook Urological, Inc. | 1997 | — |
| −1 | K072749 | Sialo Balloon Dilatation Catheter | Sialo Technology, Ltd. | 2008 | — |
| 0 (this device) | K140593 | Advance Salivary Balloon Catheter with Wire Guide | Cook, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K072749 | Sialo Balloon Dilatation CatheterSummary page 4…ication Name: Laparoscope, General & Plastic Surgery Regulation: 21 CFR §876.1500 Product Code: GCJ Predicate Devices: • K072749 Sialo Dilatation Balloon Catheter (Sialo Technologies, Ltd.). The Sialo Balloon Dilatation Catheter is designed to allow d… | 2008 |
| * | K122940 | Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3Summary page 4…ndoscopic or radiological guidance. Dilatation can be therapeutic by itself (for duct strictures), or provide endoscopic access for stone removal. • K122940 Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter (Cook Incorporated). The Advance Micro™ 14 Ultra Low-Profile PTA… | 2013 |
| * | K011084 | Mandrel Guidewire AssemblySummary page 5…ed – Traditional 510(k) 2 Advance® Salivary Balloon Catheter with Wire Guide December 12, 2014 • K011084 Mandrel Guidewires (Lake Region Manufacturing). The Mandrel Guidewires are a stainless steel core wire with a stainless s… | 2001 |
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 17 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Advance® Salivary Balloon Catheter is intended for the dilation of lesions and strictures in the submandibular and parotid salivary ducts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140593: Advance Salivary Balloon Catheter with Wire Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140593
Report an extraction error
Are you the manufacturer?
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