510(k) · Cleared
Recalled · Class I · 2013Guardian II NC Hemostasis Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zerusa Limited · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on May 21, 2010 as substantially equivalent to K092711 (Zerusa Limited, 2009) after a 30-day review. Its family tree reaches back 6 generations to 1985. 2 of the 7 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- May 21, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- DTL
- Recalls
- 2 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K854261 (1985). No later device cites it as a predicate yet. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- 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 deviceK101113 Guardian II NC Hemostasis ValveZerusa Limited · 2010
Class I recalls in this family
- K092711 Guardian II Hemostasis Valvedirect predicate · 2009
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) | K101113 | Guardian II NC Hemostasis Valve | Zerusa Limited | 2010 | — |
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
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 | Decided |
|---|---|---|---|
| * | K092711 | Guardian II Hemostasis ValveSummary page 1…n). The predicate device used to determine substantial equivalence for this device was the Zerusa Limited's currently marketed Guardian® II Hemostasis Valve (#K09271 1). 4. DEVICE DESCRIPTION: The Zerusa Guardian® II NC Hemostasis Valve is designed to be used as a conduit when inte… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| Aug 30, 2012 | Class II | Z-2400-2012 | Process control | Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination. |
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 25 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K092711.
How does its category compare?
All DTL devicesDTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DTL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTL
36in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTL
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DTL
110in 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?
The Guardian® II NC HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
The guidewire introducer is included to facilitate the guidewire's passage through the Guardian® II NC HV.
The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101113: Guardian II NC Hemostasis Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101113
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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