510(k) · Cleared
ClearedTautona Injector Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tautona Group, LLC · FMF Syringe, Piston
Cleared on Oct 22, 2013 as substantially equivalent to K083583 (Nordson Efd, 2009) and 1 other predicate after a 117-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- Oct 22, 2013
- Review
- 117 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K820164 (1982). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K820164 | Empty Sterile Carpuject | Sterling Drug, Inc. | 1982 | — |
| −2 | K063180 | Isecure Syringe Cartridge Holder | Hospira, Inc. | 2006 | — |
| −1 | K083583 | Xpresse Injection System | Nordson Efd | 2009 | — |
| 0 (this device) | K131963 | Tautona Injector Device | Tautona Group, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2005 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K083583 | Xpresse Injection SystemSummary page 1…fication Name: Syringe, Piston (21 CFR §880.5860) Product Code: FMF Equivalent Devices: Xpresse Assist / Artiste Device (K083583, cleared 30 June 2009) Tissue Trans Irrigating Syringe (K(050797, cleared 13 July 2005) Device… | 2009 |
| * | K050797 | Tissu-TransSummary page 1…F Equivalent Devices: Xpresse Assist / Artiste Device (K083583, cleared 30 June 2009) Tissue Trans Irrigating Syringe (K(050797, cleared 13 July 2005) Device Description: The TauTona Injector (TTI) Device is a hand-held, sterile, single-use, disposable dev… | 2005 |
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?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The TauTona Injector Device is a syringe assist device and is intended for use in the administration of sterile materials/ autologous adipose tissue under aseptic conditions in accordance with the best judgment of the clinician. The TauTona Injector Device is intended for use with standard syringes and cannula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131963: Tautona Injector Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131963
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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