510(k) · Cleared
Recalled · 2009Double-Swivel Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheridan Catheter Corp. · BZA Connector, Airway (Extension)
Cleared on May 14, 1985 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 5 times.
- Decided
- May 14, 1985
- Review
- 67 days
- Class
- Class I
- Product code
- BZA
- Recalls
- 5
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK850964 Double-Swivel ConnectorSheridan Catheter Corp. · 1985
- Descendant · cites it directly · 0 of its ownK083702 Trach-AssistMergenet Medical · 2009
Most influential descendants
Showing 1 of 1 · See all- K083702Trach-AssistMergenet Medical · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K850964 | Double-Swivel Connector | Sheridan Catheter Corp. | 1985 | — |
| +1 | K083702 | Trach-Assist | Mergenet Medical | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
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 BZA? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083702 | Trach-Assist | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2009 | Not classified | Z-1941-2009 | Process control | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs. |
| Jul 31, 2009 | Not classified | Z-1942-2009 | Process control | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs. |
| Jul 31, 2009 | Not classified | Z-1940-2009 | Process control | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs. |
| Jul 31, 2009 | Not classified | Z-1944-2009 | Process control | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs. |
| Jul 31, 2009 | Not classified | Z-1943-2009 | Process control | The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083702 (Mergenet Medical, 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZA devicesBZA Connector, Airway (Extension): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZA
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · BZA
Too few BZA 510(k)s in any year since 2007 to give a median.
Recalls per year · BZA
4in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BZA
25in 2025
MAUDE reports naming product code BZA, 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 | 8 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 1 | — | 6 | 17 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 82 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 0 | 21 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 4 | 13 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 0 | — | 0 | 38 |
| 2024 | 0 | — | 2 | 28 |
| 2025 | 0 | — | 4 (4) | 25 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K850964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K850964: Double-Swivel Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K850964
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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