510(k) · Cleared

Cleared

Piton (TM) Y-Pack and Piton (TM) Tri-Pack)

K945461510(k) TraditionalCleared Feb 3, 199588-day reviewClass II21 CFR 870.4290

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

Medtronics Interventional Vascular · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cleared on Feb 3, 1995 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it.

Decided: Feb 3, 1995
Review: 88 days
Class: Class II
Product code: DTL
Recalls: None
Predicates: 0

30 later devices descend from it, 1 citing it directly.

This deviceK945461 Piton (TM) Y-Pack and Piton (TM) Tri-Pack)Medtronics Interventional Vascular · 1995
Descendant · cites it directly · 29 of its ownK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
Descendant · 2 generations on · 17 of its ownK042194 Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004
Descendant · 3 generations on · 14 of its ownK053431 Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006
Descendant · 4 generations on · 13 of its ownK080428 Attain Command 6250 Left Heart Delivery Systems and Attain Command…Medtronic, Inc. · 2008
Descendant · 5 generations on · 12 of its ownK090659 Attain Command 6250 Left Heart Delivery Systems and Guide Catheters…Medtronic, Inc. · 2009

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2003high 5 (2006) · low 0 (2012)2026

Most influential descendants

Showing 5 of 30 · See all

K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003 · cites it directly29descendants
K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular · 2004 · 2 generations on17descendants
K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland · 2006 · 3 generations on14descendants
K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc. · 2008 · 4 generations on13descendants
K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc. · 2009 · 5 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945461	Piton (TM) Y-Pack and Piton (TM) Tri-Pack)	Medtronics Interventional Vascular	1995	—
+1	K031211	Attain Prevail Steerable Catheter Set, Model 6228CTH	Medtronic Vascular	2003	—
+2	K042194	Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery	Medtronic Vascular	2004	—
+3	K053431	Attain Select II 6248DEL Delivery Catheter System	Medtronic, Ireland	2006	—
+4	K080428	Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide…	Medtronic, Inc.	2008	—
+5	K090659	Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left…	Medtronic, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	2	0
2005	1	0
2006	5	0
2007	1	0
2008	2	0
2009	1	0
2010	1	0
2011	2	0
2013	1	0
2018	2	0
2019	2	0
2020	2	0
2022	1	0
2023	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K945461, 1995–2026Source: 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.

Planning a device in DTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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? (30)

See all 30

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031211	Attain Prevail Steerable Catheter Set, Model 6228CTH	Medtronic Vascular	2003	29

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?

Of its descendants, K031211 (Medtronic Vascular, 2003) has gone furthest, with 29 descendants of its own.

How does its category compare?

All DTL devices

DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTL

1in 2015

2007high 8 (2012) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTL

36in 2012

2007high 115 (2010) · low 36 (2012)2026

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

Recalls per year · DTL

1in 2025

2007high 3 (2010) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DTL

110in 2025

2007high 452 (2024) · low 16 (2008)2025

MAUDE reports naming product code DTL, 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	1	—	0	37
2008	5	85	1	16
2009	2	—	0	62
2010	4	115	3	148
2011	0	—	1	160
2012	8	36	2	53
2013	1	—	1 (1)	67
2014	2	—	1	80
2015	1	—	0	89
2016	0	—	0	67
2017	0	—	2	106
2018	0	—	0	84
2019	0	—	0	76
2020	0	—	0	53
2021	0	—	0	55
2022	0	—	2	48
2023	0	—	0	46
2024	0	—	0	452
2025	0	—	1	110
2026	0	—	3 (3)	—

https://510kreport.com/device/K945461 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945461: Piton (TM) Y-Pack and Piton (TM) Tri-Pack).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945461

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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