510(k) · Cleared

Recalled · Class I · 2016

Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve

K122301510(k) TraditionalCleared Sep 7, 201237-day reviewClass II21 CFR 870.4290Recalls 2 (2 Class I)

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

Vascular Solutions Zerusa, Ltd. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cleared on Sep 7, 2012 as substantially equivalent to K092711 (Zerusa Limited, 2009) after a 37-day review. Its family tree reaches back 6 generations to 1985. 2 of the 8 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.

Decided: Sep 7, 2012
Review: 37 days
Class: Class II
Product code: DTL
Recalls: 2 (2 Class I)
Predicates: 2

Its longest line of descent runs back 6 generations to K854261 (1985). 1 later device descends from it, 1 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
5 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
4 generations backK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
3 generations backK052381 Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005
2 generations backK073620 Guardian Hemostasis ValveZerusa Limited · 2008
1 generation backK092711 Guardian II Hemostasis ValveZerusa Limited · 2009 · Recalled (Class I)
This deviceK122301 Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd. · 2012
Descendant · cites it directly · 0 of its ownK172453 WATCHDOG Hemostasis Valve KitBoston Scientific Corporation · 2017 · Recalled

Class I recalls in this family

K092711 Guardian II Hemostasis Valvedirect predicate · 2009

Most influential descendants

Showing 1 of 1 · See all

K172453WATCHDOG Hemostasis Valve KitBoston Scientific Corporation · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K854261	Advanced Cardiovascular Systems Hemostatic Valves	Advanced Cardiovascular Systems, Inc.	1985	2
−5	K991102	Copilot Bleedback Control Valve, Model 1003331	Guidant Corp.	1999	1
−4	K042060	Easypass US Y-Connector Hemostatic Valve	Millimed A/S	2004	—
−3	K052381	Guardian Hemostasis Valve with Guidewire Introducer	Zerusa Limited	2005	—
−2	K073620	Guardian Hemostasis Valve	Zerusa Limited	2008	—
−1	K092711	Guardian II Hemostasis Valve	Zerusa Limited	2009	Class I
0 (this device)	K122301	Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve	Vascular Solutions Zerusa, Ltd.	2012	—
+1	K172453	WATCHDOG Hemostasis Valve Kit	Boston Scientific Corporation	2017	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K122301, 1985–2017Source: 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.

2 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.

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? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K100113	FDA’s K100113 is Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri… Our reading of the summary gave K100113, FDA’s number for Vanguard Breast Mri Auxiliary Table with 16 Channel Coil… (Sentinelle Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Guardian II NC”. Kept off the family tree.	Sentinelle Medical, Inc.	2010	1
*	K092711	Guardian II Hemostasis Valve Summary page 1 …manifold, or fitting; Class 11 Predicate Devices KIO0 113- Guardian 11 NC (Vascular Solutions Zerusa Limited) K092711I - Guardian 11 (Vascular Solutions Zerusa Limited) Device Description The Guardia…	Zerusa Limited	2009	Class I

Also cleared against K092711: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K172453	WATCHDOG Hemostasis Valve Kit	Boston Scientific Corporation	2017	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 4, 2016	Class I	Z-1275-2016	Employee error	Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of…
Feb 27, 2013	Class I	Z-0955-2013	Vendor change control	Risk that air may be introduced into the device which may lead to an air embolism.

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.

K092711Guardian II Hemostasis ValveZerusa Limited · 2009 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
3 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K172453 (Boston Scientific Corporation, 2017) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K092711.

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. 2012, this device’s year, is highlighted.

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)	—

What is it indicated for?

Guardian hemostasis valves are intended to maintain bemostasis during the use of diagnostic or interventional devices. Guardian bemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0. 105" or 2.67 mm) during diagnostic/interventional procedures.

The torque device is provided as an aid in steering the guidewire within the vascular anatomy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122301 · printed Nov 5, 2026

Cite this page

510(k) Report. “K122301: Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122301

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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