510(k) · Cleared

Recalled · Class II · 2022

Guider Softip Guiding Catheter XF 5F

K010853510(k) SpecialCleared Apr 18, 200128-day reviewClass II21 CFR 870.1250Recalls 17

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

Boston Scientific, Target · DQY Catheter, Percutaneous

Cleared on Apr 18, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 109 devices in its family, counting itself, have a Class I recall. 108 later devices descend from it. It has been recalled 17 times.

Decided: Apr 18, 2001
Review: 28 days
Class: Class II
Product code: DQY
Recalls: 17
Predicates: 0

108 later devices descend from it, 3 citing it directly. 4 of the 109 devices in this family, counting this one, have a Class I recall.

This deviceK010853 Guider Softip Guiding Catheter XF 5FBoston Scientific, Target · 2001
Descendant · cites it directly · 105 of its ownK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
Descendant · 2 generations on · 88 of its ownK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
Descendant · 2 generations on · 86 of its ownK083125 Neuron Select Catheter Size 070Penumbra, Inc. · 2008 · Recalled
Descendant · 2 generations on · 61 of its ownK111380 Neuron Max SystemPenumbra, Inc. · 2011
Descendant · 3 generations on · 27 of its ownK180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths…Imperative Care, Inc. · 2018

Showing 5 of 108 descendants. See all descendants

Descendants cleared per year

2007high 14 (2024) · low 0 (2009)2026

Class I recalls in this family

K192804 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA…3 generations on · 2020
K242376 Next Generation Access Platform4 generations on · 2024
K203043 Route 92 Medical 070 Access System6 generations on · 2020
K222743 Route 92 Medical Full Length 070 Access System7 generations on · 2022

Most influential descendants

Showing 5 of 108 · See all

K070970Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · cites it directly105descendants
K082290Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · 2 generations on88descendants
K083125Neuron Select Catheter Size 070Penumbra, Inc. · 2008 · 2 generations on86descendants
K111380Neuron Max SystemPenumbra, Inc. · 2011 · 2 generations on61descendants
K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…Imperative Care, Inc. · 2018 · 3 generations on27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010853	Guider Softip Guiding Catheter XF 5F	Boston Scientific, Target	2001	—
+1	K070970	Neuron Support Catheter System, Model 5F/6F	Penumbra, Inc.	2007	1
+2	K082290	Neuron Delivery Catheter 070	Penumbra, Inc.	2008	1
+2	K083125	Neuron Select Catheter Size 070	Penumbra, Inc.	2008	1
+2	K111380	Neuron Max System	Penumbra, Inc.	2011	—
+3	K180169	EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay…	Imperative Care, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	3	0
2010	2	0
2011	4	0
2012	1	0
2013	3	0
2014	1	0
2015	6	0
2016	3	0
2017	2	0
2018	3	0
2019	5	0
2020	10	2
2021	6	0
2022	9	1
2023	11	0
2024	14	1
2025	10	0
2026	14	0

FIG. 1 — Lineage of K010853, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

4 devices in this family have 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (108)

See all 108

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K070970	Neuron Support Catheter System, Model 5F/6F	Penumbra, Inc.	2007	105
K132542	Transgate Guide Catheter	Stryker Neurovascular	2013	0
K094048	Percupro Messenger Balloon Catheter	Cardiosolutions, Inc.	2011	0

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 9, 2022	Class II	Z-1582-2022	Process control	The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
Dec 11, 2017	Class II	Z-2735-2018	Process change control	Potential polymer material degradation.
Oct 5, 2016	Class II	Z-0338-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0340-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0341-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0342-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0344-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0337-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0343-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0333-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0335-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0346-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0347-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0334-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0336-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0339-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Oct 5, 2016	Class II	Z-0345-2017	Employee error	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.

The 5 latest of 17 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA…Medos International SARL · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
K242376Next Generation Access PlatformBalt USA, LLC · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc. · 2022 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K070970 (Penumbra, Inc., 2007) has gone furthest, with 105 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

https://510kreport.com/device/K010853 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010853: Guider Softip Guiding Catheter XF 5F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010853

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026