510(k) · Cleared
ClearedDillard Nasal Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuit Medical Products, LLC · LRC Instrument, Ent Manual Surgical
Cleared on Jan 3, 2020 as substantially equivalent to K183090 (Acclarent, Inc., 2019) after a 570-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Jan 3, 2020
- Review
- 570 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K183090 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK183090 Relieva Tract Balloon Dilation SystemAcclarent, Inc. · 2019
- This deviceK181546 Dillard Nasal Balloon CatheterIntuit Medical Products, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K183090 | Relieva Tract Balloon Dilation System | Acclarent, Inc. | 2019 | — |
| 0 (this device) | K181546 | Dillard Nasal Balloon Catheter | Intuit Medical Products, LLC | 2020 | — |
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 LRC? 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 LRC device
- #1 K230258 BB 8 Sinus Dilation Kitscore 11.1 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K183090 | Relieva Tract Balloon Dilation System Cleared while this submission was under review Summary page 4…QGK, 21 CFR 874.4420 Class I E. Predicate Devices: Acclarant RELIEVA TRACT™ Balloon Dilation System, K183090 Additional Reference Devices (for technological comparison ONLY): ECONOM™ speculum for ENT applications, K925… | 2019 |
| † | K925754 | Econom | 1993 |
| † | K143738 | DSS Sinusplasty Balloon Catheter | 2015 |
| † | K153484 | Dillard Airway Dilatation System | 2016 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LRC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LRC
131in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRC
44in 2025
MAUDE reports naming product code LRC, 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 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 2 | — | 0 | 11 |
| 2011 | 6 | 106 | 0 | 14 |
| 2012 | 7 | 50 | 0 | 48 |
| 2013 | 7 | 104 | 0 | 53 |
| 2014 | 3 | 29 | 0 | 53 |
| 2015 | 6 | 105 | 0 | 41 |
| 2016 | 3 | 100 | 0 | 39 |
| 2017 | 2 | — | 0 | 32 |
| 2018 | 1 | — | 0 | 42 |
| 2019 | 1 | — | 0 | 19 |
| 2020 | 4 | 131 | 0 | 20 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 1 | — | 0 | 25 |
| 2023 | 1 | — | 1 | 14 |
| 2024 | 0 | — | 1 | 51 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dillard Nasal Balloon (DNB) Catheter is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum.
The Dillard Nasal Balloon (DNB) Catheter is intended for use in ages 17 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181546: Dillard Nasal Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181546
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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