510(k) · Cleared

Cleared

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand

K190715510(k) TraditionalCleared Dec 13, 2019269-day reviewClass II21 CFR 874.4250

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

Interscope, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Cleared on Dec 13, 2019 as substantially equivalent to K041413 (Medtronic Xomed, Inc., 2004) after a 269-day review. Its family tree reaches back 2 generations to 2000.

Decided: Dec 13, 2019
Review: 269 days
Class: Class II
Product code: ERL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K002224 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002224 XPS 3000 SystemMedtronic Xomed · 2000
1 generation backK041413 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
This deviceK190715 EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap…Interscope, Inc. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002224	XPS 3000 System	Medtronic Xomed	2000	—
−1	K041413	XPS 3000 System	Medtronic Xomed, Inc.	2004	—
0 (this device)	K190715	EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor…	Interscope, Inc.	2019	—

FIG. 1 — Lineage of K190715, 2000–2019Source: 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 ERL? 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 ERL device

#1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 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
*	K041413	XPS 3000 System Summary page 4 …er: Medtronic XOMED Proprietary Name: XPS 3000 System Classification Name: ENT Surgical Drill 510(k) Number: K041413 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Classification Regulation: 21 C…	Medtronic Xomed, Inc.	2004	—
†	K181127	EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set…	Interscope, Inc.	2019	—

Also cleared against K041413: 4 other devices →

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 19 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
None of the 2 ancestors has a recall.
4 other devices also cite its predicate K041413.

How does its category compare?

All ERL devices

ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · ERL

1in 2025

2007high 6 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ERL

191in 2022

2007high 191 (2022) · low 86 (2015)2026

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

Recalls per year · ERL

1in 2021

2007high 5 (2020) · low 0 (2007)2026

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

Adverse event reports per year · ERL

1,469in 2025

2007high 3,231 (2013) · low 60 (2008)2025

MAUDE reports naming product code ERL, 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	112
2008	6	181	0	60
2009	1	—	1	249
2010	0	—	0	444
2011	0	—	0	1,068
2012	2	—	0	1,379
2013	2	—	3	3,231
2014	1	—	0	1,975
2015	3	86	0	2,630
2016	4	180	0	1,455
2017	2	—	0	999
2018	1	—	0	1,380
2019	1	—	0	2,515
2020	1	—	5	2,369
2021	1	—	1	2,283
2022	3	191	0	1,574
2023	0	—	0	1,725
2024	1	—	0	1,588
2025	1	—	0	1,469
2026	0	—	0	—

What is it indicated for?

The EndoRotor® System is intended for use in airway procedures including removal of granulation tissue and endobronchial lesions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190715 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190715: EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190715

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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