510(k) · Cleared
ClearedFahl Tracheostomy Tubes (Multiple)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andreas Fahl Medizintechnik-Vertrieb GmbH · JOH Tube Tracheostomy And Tube Cuff
Cleared on Aug 12, 2013 as substantially equivalent to K120079 (Primed Halberstadt Medizintechnik GmbH, 2012) and 2 other predicates after a 252-day review. Its family tree reaches back 3 generations to 1978. 1 later device descends from it.
- Decided
- Aug 12, 2013
- Review
- 252 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K781729 (1978). 23 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK781729 Tracheotomy TubesTracoe Medical GmbH · 1978
- 2 generations backK961449 Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH · 1996
- 1 generation backK120079 Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012
- This deviceK123699 Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013
- Descendant · cites it directly · 0 of its ownK233713 Pilling Tracheostomy TubesTeleflex Medical · 2024
Most influential descendants
Showing 1 of 1 · See all- K233713Pilling Tracheostomy TubesTeleflex Medical · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K781729 | Tracheotomy Tubes | Tracoe Medical GmbH | 1978 | — |
| −2 | K961449 | Tracheostomy Tubes Tracoe-Flex | Tracoe Medical GmbH | 1996 | — |
| −1 | K120079 | Primed Tracheostomy Tubes (Multiple) | Primed Halberstadt Medizintechnik GmbH | 2012 | — |
| 0 (this device) | K123699 | Fahl Tracheostomy Tubes (Multiple) | Andreas Fahl Medizintechnik-Vertrieb GmbH | 2013 | — |
| +1 | 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 |
|---|---|---|
| 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 JOH? 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 JOH device
- #1 K251313 Shiley™ Adult Flexible Tracheostomy Tube XLT…score 11.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K120079 | Primed Tracheostomy Tubes (Multiple)Summary page 1…use and similar design and technological characteristics. Substantially equivalence of the FahuI Tracheostomy Tubes is claimed to the following predicate devices: * K120079 Primed Tracheostomy Tubes (Multiple) by Primed * K961449 Tracoe Twist Tracheostomy Tubes by Tracoe * K912124 Tracheostomy… | 2012 |
| * | K961449 | Tracheostomy Tubes Tracoe-FlexSummary page 1…bstantially equivalence of the FahuI Tracheostomy Tubes is claimed to the following predicate devices: * K120079 Primed Tracheostomy Tubes (Multiple) by Primed * K961449 Tracoe Twist Tracheostomy Tubes by Tracoe * K912124 Tracheostomy Tube and Cuff by Portex 4 DEVICE DESCRIPTION The FahN Trach… | 1996 |
| * | K912124 | Tracheostomy Tube and CuffSummary page 1…is claimed to the following predicate devices: * K120079 Primed Tracheostomy Tubes (Multiple) by Primed * K961449 Tracoe Twist Tracheostomy Tubes by Tracoe * K912124 Tracheostomy Tube and Cuff by Portex 4 DEVICE DESCRIPTION The FahN Tracheostomy Tubes (Duravent, Duracuff, Laryngotec, Duratwix,… | 1991 |
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 |
|---|---|---|---|
| K233713 | Pilling Tracheostomy Tubes | 2024 | 0 |
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 35 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K233713 (Teleflex Medical, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JOH devicesJOH Tube Tracheostomy And Tube Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JOH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOH
137in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOH
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · JOH
986in 2025
MAUDE reports naming product code JOH, 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 | — | 1 | 167 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 1 | 195 |
| 2010 | 2 | — | 73 | 1,270 |
| 2011 | 0 | — | 4 | 587 |
| 2012 | 1 | — | 0 | 500 |
| 2013 | 3 | 407 | 0 | 544 |
| 2014 | 3 | 218 | 0 | 506 |
| 2015 | 3 | 179 | 0 | 508 |
| 2016 | 1 | — | 2 (1) | 572 |
| 2017 | 1 | — | 0 | 441 |
| 2018 | 3 | 137 | 0 | 812 |
| 2019 | 2 | — | 0 | 1,019 |
| 2020 | 1 | — | 1 | 791 |
| 2021 | 2 | — | 0 | 1,041 |
| 2022 | 0 | — | 0 | 1,632 |
| 2023 | 0 | — | 1 | 1,233 |
| 2024 | 0 | — | 0 | 1,103 |
| 2025 | 1 | — | 0 | 986 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Fahi Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomnized patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123699 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123699: Fahl Tracheostomy Tubes (Multiple).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123699
Report an extraction error
Are you the manufacturer?
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