510(k) · Cleared
ClearedSuction Safety Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R D Intl. · MJJ Cpb Check Valve, Retrograde Flow, In-Line
Cleared on Jun 5, 1996 as substantially equivalent to K760894 (Delta Medical Industries, 1976) after an 89-day review. Its family tree reaches back 1 generation to 1976.
- Decided
- Jun 5, 1996
- Review
- 89 days
- Class
- Class II
- Product code
- MJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K760894 (1976). No later device cites it as a predicate yet.
- Root · 1 generation backK760894 Vacuum Relief ValveDelta Medical Industries · 1976
- This deviceK960937 Suction Safety DeviceR D Intl. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760894 | Vacuum Relief Valve | Delta Medical Industries | 1976 | — |
| 0 (this device) | K960937 | Suction Safety Device | R D Intl. | 1996 | — |
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 |
|---|---|---|---|
| * | K760894 | Vacuum Relief ValveSummary page 1…ation: Class I1 V. Safety and Effectiveness: Substantial Equivalence: This device has been shown to be substantially equivalent to the Delta Vacuum Relief Valve 510(k) 760894. VI. Other Safety and Effectiveness Data: Material: Fluid contact materials of construction comply with Tripartite Biocompatibi… | 1976 |
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.
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.
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 RDI Suction Safety Device is intended to be used during open heart surgery and placed in a suction line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.
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/K960937 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960937: Suction Safety Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960937
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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