510(k) · Cleared
ClearedEnteraLoc Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vonco Products · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Aug 18, 2021 as substantially equivalent to K163586 (Trovrx, Inc. Dba Trovita Health Science, 2017) and 1 other predicate after a 140-day review. Its family tree reaches back 9 generations to 1980. 1 later device descends from it.
- Decided
- Aug 18, 2021
- Review
- 140 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K801558 (1980). 30 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 5 generations between
- 3 generations backK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- 2 generations backK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
- 1 generation backK183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low…Neomed, Inc. · 2019
- This deviceK210971 EnteraLoc FlowVonco Products · 2021
- Descendant · cites it directly · 0 of its ownK223683 EnteraLoc FlowVonco Products · 2023
Show all 9 generations
- Root · 9 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 8 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 7 generations backK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- 6 generations backK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
- 5 generations backK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- 4 generations backK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
- 3 generations backK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- 2 generations backK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
- 1 generation backK183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low…Neomed, Inc. · 2019
- This deviceK210971 EnteraLoc FlowVonco Products · 2021
Most influential descendants
Showing 1 of 1 · See all- K223683EnteraLoc FlowVonco Products · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −8 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −7 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| −6 | K100099 | Oral/Enteral Syringes | Philips Children'S Medical Ventures | 2010 | — |
| −5 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| −4 | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
| −3 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible… | Neomed, Inc. | 2015 | — |
| −2 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and… | Neomed, Inc. | 2016 | — |
| −1 | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip… | Neomed, Inc. | 2019 | — |
| 0 (this device) | K210971 | EnteraLoc Flow | Vonco Products | 2021 | — |
| +1 | K223683 | EnteraLoc Flow | Vonco Products | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 PIF? 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 PIF device
- #1 K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi…score 15.5 · 13 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 |
|---|---|---|---|
| * | K163586 | Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorSummary page 5…10(k) 5.3 Predicate Device The Vonco Products EnteraLoc Flow spouted pouch with ENFit Connector is substantially equivalent to the following devices: • K163586 – Trovita Health Science Safe-T Feed Ready-To-Feed Pouch with ENFit Connector • K183540 – NeoMed Oral/Enteral Syringes with… | 2017 |
| * | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…Summary page 5…Connector is substantially equivalent to the following devices: • K163586 – Trovita Health Science Safe-T Feed Ready-To-Feed Pouch with ENFit Connector • K183540 – NeoMed Oral/Enteral Syringes with ENFit Connector 5.4 Device Description The Vonco Products EnteraLoc Flow pouch with ENF… | 2019 |
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 |
|---|---|---|---|
| K223683 | EnteraLoc Flow | 2023 | 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 41 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 30 ancestors have a recall of any class.
- Of its descendants, K223683 (Vonco Products, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PIF devicesPIF Gastrointestinal Tubes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PIF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIF
242in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIF
83in 2025
MAUDE reports naming product code PIF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 119 | 0 | 0 |
| 2015 | 9 | 143 | 106 | 12 |
| 2016 | 3 | 267 | 0 | 45 |
| 2017 | 5 | 174 | 0 | 17 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 7 | 135 | 0 | 28 |
| 2020 | 4 | 165 | 0 | 70 |
| 2021 | 4 | 242 | 0 | 89 |
| 2022 | 4 | 167 | 0 | 77 |
| 2023 | 4 | 242 | 0 | 96 |
| 2024 | 2 | — | 1 | 110 |
| 2025 | 2 | — | 0 | 83 |
| 2026 | 3 | 239 | 0 | — |
What is it indicated for?
The EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210971: EnteraLoc Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210971
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