510(k) · Cleared
ClearedDASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intervene Group Limited · PNR Enteral Syringes With Enteral Specific Connectors
Cleared on Oct 20, 2017 as substantially equivalent to K161963 (Covidien, 2016) and 3 other predicates after a 256-day review. Its family tree reaches back 9 generations to 1980.
- Decided
- Oct 20, 2017
- Review
- 256 days
- Class
- Class II
- Product code
- PNR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K801558 (1980). 23 ancestors in all. No later device cites it as a predicate yet.
- 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 backK160419 Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien · 2016
- 1 generation backK161963 Monoject Enteral Syringe with ENFit ConnectorCovidien · 2016
- This deviceK170371 DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus…Intervene Group Limited · 2017
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 backK160419 Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien · 2016
- 1 generation backK161963 Monoject Enteral Syringe with ENFit ConnectorCovidien · 2016
- This deviceK170371 DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus…Intervene Group Limited · 2017
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 | K160419 | Monoject Enteral Feeding Syringe with ENFit Connector | Covidien | 2016 | — |
| −1 | K161963 | Monoject Enteral Syringe with ENFit Connector | Covidien | 2016 | — |
| 0 (this device) | K170371 | DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit… | Intervene Group Limited | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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 PNR? 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 PNR device
- #1 K252483 Enteral Syringe (20ml, 60ml)score 14.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K161963 | Monoject Enteral Syringe with ENFit ConnectorSummary page 6…Oral/Enteral Syringes ENFit Connector with ENFit Connectors Manufacturer and Covidien NeoMed, Inc. Clearance Number: K161963 K161039 K161045 Product Code: PNR PNR Classification Enter… | 2016 |
| * | K161045 | MonojectSummary page 6…nnector with ENFit Connectors Manufacturer and Covidien NeoMed, Inc. Clearance Number: K161963 K161039 K161045 Product Code: PNR PNR Classification Enteral Syringes with Enteral Syringes with Name:… | 2016 |
| * | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsSummary page 6…Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps Manufacturer and NeoMed, Inc. Clearance Number: K152857 Product Code: PIF Classification Gastrointestinal Tube and accessories Name:… | 2015 |
| * | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Summary page 6…ENFit Connector with ENFit Connectors Manufacturer and Covidien NeoMed, Inc. Clearance Number: K161963 K161039 K161045 Product Code: PNR PNR Classification Enteral Syringes with Enter… | 2016 |
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 37 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 23 ancestors have a recall of any class.
- 1 other device also cites its predicate K161963.
How does its category compare?
All PNR devicesPNR Enteral Syringes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PNR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNR
129in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNR
4in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · PNR
7in 2025
MAUDE reports naming product code PNR, 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 | 0 | — | 0 | 0 |
| 2015 | 3 | 139 | 0 | 0 |
| 2016 | 6 | 65 | 0 | 1 |
| 2017 | 5 | 247 | 0 | 3 |
| 2018 | 3 | 133 | 0 | 2 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 3 | 209 | 0 | 3 |
| 2021 | 5 | 129 | 0 | 5 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 2 | — | 4 (4) | 11 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The DASH 3™ ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age…
Read the full statement (275 words)
The DASH 3™ ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
The DASH 3™ Eccentric ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
The DASH 3™ Low Volume Tip ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
The DASH 3™ ENFit Syringe Cap allows the advance preparation and secure storage and transport of medication/fluids or nutritional formula. The syringe cap will fit any size of the Single Use Syringes (DASH 3™).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170371: DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170371
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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