510(k) · Cleared

Cleared

ACCLARENT SE Inflation Device

K150172510(k) SpecialCleared Apr 7, 201571-day reviewClass I21 CFR 874.4420

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Acclarent, Inc. · LRC Instrument, Ent Manual Surgical

Cleared on Apr 7, 2015 as substantially equivalent to K052198 (Acclarent, Inc., 2005) after a 71-day review. Its family tree reaches back 2 generations to 2005.

Decided: Apr 7, 2015
Review: 71 days
Class: Class I
Product code: LRC
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K043527 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK043527 Relieva Sinus Balloon Dilation CatheterExploramed Nc1, Inc. · 2005
1 generation backK052198 Relieva Sinus Balloon Inflation DeviceAcclarent, Inc. · 2005
This deviceK150172 ACCLARENT SE Inflation DeviceAcclarent, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K043527	Relieva Sinus Balloon Dilation Catheter	Exploramed Nc1, Inc.	2005	—
−1	K052198	Relieva Sinus Balloon Inflation Device	Acclarent, Inc.	2005	—
0 (this device)	K150172	ACCLARENT SE Inflation Device	Acclarent, Inc.	2015	—

FIG. 1 — Lineage of K150172, 2005–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K052198	Relieva Sinus Balloon Inflation Device Summary page 4 …ame: Ear, nose, and throat manual surgical instrument Product Code: LRC Predicate Devices: Acclarent Balloon Inflation Device (K052198) Device Description: The ACCLARENT SE Inflation Device is an instrument intended to inflate,…	Acclarent, Inc.	2005	—

Also cleared against K052198: 1 other device →

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 10 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K052198.

How does its category compare?

All LRC devices

LRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · LRC

1in 2023

2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRC

131in 2020

2007high 131 (2020) · low 29 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LRC

1in 2024

2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LRC

44in 2025

2007high 53 (2013) · low 0 (2008)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 ACCLARENT® SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150172 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150172: ACCLARENT SE 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/K150172

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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