510(k) · Cleared
ClearedPrimed Tracheostomy Tubes (Multiple)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primed Halberstadt Medizintechnik GmbH · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on May 24, 2012 as substantially equivalent to K051587 (Tracoe Medical GmbH, 2005) and 6 other predicates after a 135-day review. Its family tree reaches back 2 generations to 1978. 2 later devices descend from it.
- Decided
- May 24, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- BTO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K781729 (1978). 22 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK781729 Tracheotomy TubesTracoe Medical GmbH · 1978
- 1 generation backK961449 Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH · 1996
- This deviceK120079 Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012
- Descendant · cites it directly · 1 of its ownK123699 Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013
- Descendant · 2 generations on · 0 of its ownK233713 Pilling Tracheostomy TubesTeleflex Medical · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K781729 | Tracheotomy Tubes | Tracoe Medical GmbH | 1978 | — |
| −1 | K961449 | Tracheostomy Tubes Tracoe-Flex | Tracoe Medical GmbH | 1996 | — |
| 0 (this device) | K120079 | Primed Tracheostomy Tubes (Multiple) | Primed Halberstadt Medizintechnik GmbH | 2012 | — |
| +1 | K123699 | Fahl Tracheostomy Tubes (Multiple) | Andreas Fahl Medizintechnik-Vertrieb GmbH | 2013 | — |
| +2 | K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 4 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2024 | 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 BTO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTO device
- #1 K242921 5300600-5301000 Rota-Trach Disposable Standard…score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K051587 | Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460, 465, 470Summary page 2…, speaking valve, Humid Moist Exchanger (HME) as well as a suction function. As an example the following predicate devices are mentioned here*: *KO051587 Tracoe-Vario, Tracheostomy Tubes (various) *K043160 Tracoe Phone Assist *K961449 Tracheostomy… | 2005 |
| * | K043160 | Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist I-650-T/to and…Summary page 2…suction function. As an example the following predicate devices are mentioned here*: *KO051587 Tracoe-Vario, Tracheostomy Tubes (various) *K043160 Tracoe Phone Assist *K961449 Tracheostomy Tubes Tracoe-flex 1781729 K Tr… | 2005 |
| * | K961449 | Tracheostomy Tubes Tracoe-FlexSummary page 2…ng predicate devices are mentioned here*: *KO051587 Tracoe-Vario, Tracheostomy Tubes (various) *K043160 Tracoe Phone Assist *K961449 Tracheostomy Tubes Tracoe-flex 1781729 K Tracheostomy Tubes 1083641… | 1996 |
| * | K781729 | Tracheotomy TubesSummary page 2…O051587 Tracoe-Vario, Tracheostomy Tubes (various) *K043160 Tracoe Phone Assist *K961449 Tracheostomy Tubes Tracoe-flex 1781729 K Tracheostomy Tubes 1083641 K Bivona Tracheostomy Tube (silicone) by S… | 1978 |
| * | K083641 | Bivona Tracheostomy TubesSummary page 2…*K043160 Tracoe Phone Assist *K961449 Tracheostomy Tubes Tracoe-flex 1781729 K Tracheostomy Tubes 1083641 K Bivona Tracheostomy Tube (silicone) by Smith Medical ASD 1013321 K Tr… | 2009 |
| * | K013321 | Silicone Tracheal T-TubesSummary page 2…1781729 K Tracheostomy Tubes 1083641 K Bivona Tracheostomy Tube (silicone) by Smith Medical ASD 1013321 K Tracheal/Thoracic T-Tube by Technical Products, Inc. *K063125 Filterflo HEPA by ARC Medica… | 2002 |
| * | K063125 | Filterflo Hepa; Thermoflo Hepa (Filter / Hme)Summary page 2…Bivona Tracheostomy Tube (silicone) by Smith Medical ASD 1013321 K Tracheal/Thoracic T-Tube by Technical Products, Inc. *K063125 Filterflo HEPA by ARC Medical, Inc. *Not mentioned here are the predicates, which are now 510(k) exempt. IV. Desc… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123699 | Fahl Tracheostomy Tubes (Multiple) | 2013 | 1 |
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?
- The line of descent spans 34 years and passes through 2 companies; a new generation was cleared every 17.9 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K123699 (Andreas Fahl Medizintechnik-Vertrieb GmbH, 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K051587.
How does its category compare?
All BTO devicesBTO Tube, Tracheostomy (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · BTO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTO
98in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTO
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BTO
233in 2025
MAUDE reports naming product code BTO, 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 | 226 |
| 2008 | 1 | — | 0 | 255 |
| 2009 | 1 | — | 2 | 795 |
| 2010 | 3 | 98 | 6 | 130 |
| 2011 | 1 | — | 19 | 54 |
| 2012 | 1 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 78 |
| 2014 | 0 | — | 0 | 173 |
| 2015 | 0 | — | 1 | 172 |
| 2016 | 0 | — | 0 | 212 |
| 2017 | 0 | — | 0 | 126 |
| 2018 | 1 | — | 0 | 162 |
| 2019 | 0 | — | 0 | 87 |
| 2020 | 1 | — | 0 | 113 |
| 2021 | 0 | — | 0 | 198 |
| 2022 | 0 | — | 0 | 770 |
| 2023 | 0 | — | 1 (1) | 402 |
| 2024 | 1 | — | 0 | 418 |
| 2025 | 1 | — | 0 | 233 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Primed Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120079: Primed Tracheostomy Tubes (Multiple).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120079
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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