510(k) · Cleared
ClearedDeka Tac Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka Research & Development Corp. · FIG Clamp, Tubing, Blood, Automatic
Cleared on Aug 23, 2011 as substantially equivalent to K914459 (Rocky Mountain Research, Inc., 1992) and 1 other predicate after a 609-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Aug 23, 2011
- Review
- 609 days
- Class
- Class II
- Product code
- FIG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914459 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914459 Automatic Tubing ClampRocky Mountain Research, Inc. · 1992
- This deviceK093915 Deka Tac DeviceDeka Research & Development Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914459 | Automatic Tubing Clamp | Rocky Mountain Research, Inc. | 1992 | — |
| 0 (this device) | K093915 | Deka Tac Device | Deka Research & Development Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 FIG? 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? (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 |
|---|---|---|---|
| * | K914459 | Automatic Tubing ClampSummary page 1…lly equivalent (i.e., has the same intended use and similar technological characteristics) to the Rocky Mt. Research Automatic Tubing Clamp System (K9 14459) and the Medivice SidePort Pinch Clamp Device (K010888). DEKA bases this claim of substantial equivalence on intended… | 1992 |
| * | K010888 | Sideport Pinch Clamp DeviceSummary page 1…lar technological characteristics) to the Rocky Mt. Research Automatic Tubing Clamp System (K9 14459) and the Medivice SidePort Pinch Clamp Device (K010888). DEKA bases this claim of substantial equivalence on intended use and in recognition that the differences… | 2001 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All FIG devicesFIG Clamp, Tubing, Blood, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FIG
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · FIG
Too few FIG 510(k)s in any year since 2007 to give a median.
Recalls per year · FIG
No recall names FIG since 2007.
Adverse event reports per year · FIG
No MAUDE report names FIG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DEKA TAG is an automatic tubing clamp device intended for use in a clinical facility as an accessory to a hemodialysis blood circuit to automatically clamp the blood flow in the hemodialysis circuit upon detection of tension in the venous access line in excess of a pre-defined threshold value. The DEKA TAG may be mounted on, or removed from, already assembled hemodialysis blood circuits.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093915 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093915: Deka Tac Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093915
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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