510(k) · Cleared
ClearedTrach-Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mergenet Medical · BZA Connector, Airway (Extension)
Cleared on Mar 5, 2009 as substantially equivalent to K850964 (Sheridan Catheter Corp., 1985) and 3 other predicates after an 80-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Mar 5, 2009
- Review
- 80 days
- Class
- Class I
- Product code
- BZA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K770771 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK770771 Aerosol Effusion System #1740Hudson Oxygen Therapy Sales Co. · 1977
- This deviceK083702 Trach-AssistMergenet Medical · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770771 | Aerosol Effusion System #1740 | Hudson Oxygen Therapy Sales Co. | 1977 | — |
| 0 (this device) | K083702 | Trach-Assist | Mergenet Medical | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 2007 | 1 | 0 |
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 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? (4)
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 |
|---|---|---|---|
| * | K850964 | Double-Swivel ConnectorSummary page 1…n) Connector Classification Name: Airway (extension) Connector BZA- 868.5810 Predicate Devices: K850964 - Sheridan (Teleflex) Double Swivel K833373 - Sontek Bodai Swivel… | 1985 |
| * | K833373 | Bodia Bronch-Saf Double SwivelSummary page 1…tor BZA- 868.5810 Predicate Devices: K850964 - Sheridan (Teleflex) Double Swivel K833373 - Sontek Bodai Swivel K770771 - Hudson RCI (Teleflex) Water Trap… | 1983 |
| * | K770771 | Aerosol Effusion System #1740Summary page 1…ate Devices: K850964 - Sheridan (Teleflex) Double Swivel K833373 - Sontek Bodai Swivel K770771 - Hudson RCI (Teleflex) Water Trap K063125 - ARC Medical HME Device Description: Trach-Assist… | 1977 |
| * | K063125 | Filterflo Hepa; Thermoflo Hepa (Filter / Hme)Summary page 1…K833373 - Sontek Bodai Swivel K770771 - Hudson RCI (Teleflex) Water Trap K063125 - ARC Medical HME Device Description: Trach-Assist is a simple connector with standard 15 mm fittings permitting connection with… | 2007 |
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?
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All BZA devicesBZA Connector, Airway (Extension): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Trach-Assist is an airway connector intended to connect between an endotracheal tube or tracheostomy tube and the ventilator circuit or closed suction system. It can assist in removal of patient secretions that may collect in ventilatory tubing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083702: Trach-Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083702
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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