510(k) · Cleared

Recalled · Class I · 2024

CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm

K192804510(k) TraditionalCleared Feb 27, 2020149-day reviewClass II21 CFR 870.1250Recalls 1 (1 Class I)

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

Medos International SARL · QJP Catheter, Percutaneous, Neurovasculature

Cleared on Feb 27, 2020 as substantially equivalent to K111380 (Penumbra, Inc., 2011) and 2 other predicates after a 149-day review. Its family tree reaches back 6 generations to 2001. 1 of the 13 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided: Feb 27, 2020
Review: 149 days
Class: Class II
Product code: QJP
Recalls: 1 (1 Class I)
Predicates: 3

Its longest line of descent runs back 6 generations to K010954 (2001). 12 ancestors in all, the oldest K010853 (2001). No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 6 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
5 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
4 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
3 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
2 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
1 generation backK111380 Neuron Max SystemPenumbra, Inc. · 2011
This deviceK192804 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm…Medos International SARL · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K010954	Concentric Balloon Guide Catheter, Model 90031	Concentric Medical, Inc.	2001	1
−5	K021899	Concentric Balloon Guide Catheter, Model 90072	Concentric Medical, Inc.	2002	1
−4	K053491	Penumbra Balloon Guide Catheter, Model 7.5F	Penumbra, Inc.	2006	—
−3	K070970	Neuron Support Catheter System, Model 5F/6F	Penumbra, Inc.	2007	1
−2	K082290	Neuron Delivery Catheter 070	Penumbra, Inc.	2008	1
−1	K111380	Neuron Max System	Penumbra, Inc.	2011	—
0 (this device)	K192804	CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA…	Medos International SARL	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2008	1	0
2009	1	0
2012	1	0
2014	2	0

FIG. 1 — Lineage of K192804, 2001–2020Source: 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.

1 device in this family has a Class I recall. 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 QJP device

#1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 6 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? (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	Applicant	Decided	Recalls
*	K111380	Neuron Max System Summary page 4 …Date Cleared Name Manufacturer Number K111380 07/19/2011 Neuron MAX System Penumbra, Inc. K140080 04/2…	Penumbra, Inc.	2011	—
*	K140080	Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB… Summary page 4 …Number K111380 07/19/2011 Neuron MAX System Penumbra, Inc. K140080 04/24/2014 ENVOY DA Guiding Catheter Medos International…	Codman & Shurtleff, Inc.	2014	—
*	K140307	Envoy Guiding Catheter Summary page 4 …Medos International SARL K140307 04/21/2014 ENVOY Guiding Catheter Codman & Shurtleff,…	Codman & Shurtleff, Inc.	2014	—

Also cleared against K111380: 9 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 2, 2024	Class I	Z-1284-2024	Under Investigation by firm	Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

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 2.7 years on median.
6 of the 12 ancestors have a recall of any class.
9 other devices also cite its predicate K111380.

How does its category compare?

All QJP devices

QJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · QJP

22so far in 2026, the most since 2007

2007high 22 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJP

116in 2025

2007high 206 (2022) · low 72 (2020)2026

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

Recalls per year · QJP

1in 2024

2007high 1 (2024) · low 0 (2007)2026

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

Adverse event reports per year · QJP

688in 2025

2007high 688 (2025) · low 0 (2007)2025

MAUDE reports naming product code QJP, 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	0
2008	0	—	0	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	9	72	0	16
2021	12	139	0	29
2022	14	206	0	30
2023	14	184	0	75
2024	18	188	1	130
2025	14	116	0	688
2026	22	141	0	—

What is it indicated for?

The CEREBASE DA Guide Sheath is indicated for the introduction of interventional devices into the neuro vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K192804 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192804: CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192804

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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