510(k) · Cleared
ClearedMiniGuard Arterial Safety Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Medical, Inc. · MJJ Cpb Check Valve, Retrograde Flow, In-Line
Cleared on Nov 6, 2018 as substantially equivalent to K922356 (American Omni Medical, Inc., 1993) after a 60-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 6, 2018
- Review
- 60 days
- Class
- Class II
- Product code
- MJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922356 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK922356 Flow Control Valve, Cat. NO. Acv-38American Omni Medical, Inc. · 1993
- This deviceK182442 MiniGuard Arterial Safety ValveQuest Medical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922356 | Flow Control Valve, Cat. NO. Acv-38 | American Omni Medical, Inc. | 1993 | — |
| 0 (this device) | K182442 | MiniGuard Arterial Safety Valve | Quest Medical, Inc. | 2018 | — |
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.
Planning a device in MJJ? 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 |
|---|---|---|---|
| * | K922356 | Flow Control Valve, Cat. NO. Acv-38Summary page 5…ine CLASSIFICATION NAME: Cardiopulmonary Bypass Blood Reservoir CLASSIFICATION NUMBER: 870.4400 CLASS: Class II PRODUCT CODE: MJJ PREDICATE DEVICE K922356, RetroGuard Arterial Safety Valve DEVICE DESCRIPTION The MiniGuard Arterial Safety Valve ensures unidirectional flow in a bloo… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K922356.
How does its category compare?
All MJJ devicesMJJ Cpb Check Valve, Retrograde Flow, In-Line: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MJJ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MJJ
Too few MJJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MJJ
36in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJJ
1in 2019
MAUDE reports naming product code MJJ, 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 | — | 36 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MiniGuard™ Arterial Safety Valve is intended to be used in an Extracorporeal Circuit during cardiopulmonary bypass procedures for the prevention of retrograde flow.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182442: MiniGuard Arterial Safety Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182442
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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