510(k) · Cleared
ClearedSafety Screw Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Apr 20, 2012 as substantially equivalent to K943240 (Abbott Laboratories, 1995) and 1 other predicate after a 123-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Apr 20, 2012
- Review
- 123 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915735 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915735 Flexiflo Quantum Ent. Pump Sets and Ent. Nut. ContAbbott Laboratories · 1992 · Recalled
- This deviceK113719 Safety Screw ConnectorAbbott Laboratories · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915735 | Flexiflo Quantum Ent. Pump Sets and Ent. Nut. Cont | Abbott Laboratories | 1992 | 1 |
| 0 (this device) | K113719 | Safety Screw Connector | Abbott Laboratories | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 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 |
|---|---|---|---|
| * | K943240 | Flexiflo Six Enteral Nutrition Pump SetSummary page 2…being used for currently marketed competitive enteral nutrition sets. This bundled 510(k) is a modification of the following three Class 2 nutrition devices: *K1943240 Flexiflo®& Six Enteral Nutrition Pump Set: ICNT, Class 2, 876.5980, Gastroenterology/Urology (currently marketed as the P… | 1995 |
| * | K915735 | Flexiflo Quantum Ent. Pump Sets and Ent. Nut. ContSummary page 2…& Six Enteral Nutrition Pump Set: ICNT, Class 2, 876.5980, Gastroenterology/Urology (currently marketed as the Patrol® Pump Set with Piercing Pin) e K915735 Flexiflo®& Quantum Enteral Pump Sets and Enteral Nutrition Containers: KNT, Class 2, 876.5980, Gastroenterology/Urology (c… | 1992 |
| * | — | PREAMENDMENT Gravity Feeding Sets Named without a submission number |
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?
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The sets are intended to deliver liquid nutrition formulas or water to an enteral access device (a feeding tube).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113719: Safety Screw Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113719
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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