510(k) · Cleared
ClearedOral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neomed, Inc. · PNR Enteral Syringes With Enteral Specific Connectors
Cleared on Apr 30, 2019 as substantially equivalent to K161039 (Neomed, Inc., 2016) after a 131-day review. Its family tree reaches back 8 generations to 1980. 5 later devices descend from it.
- Decided
- Apr 30, 2019
- Review
- 131 days
- Class
- Class II
- Product code
- PNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K801558 (1980). 20 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 7 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 6 generations backK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- 5 generations backK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
- 4 generations backK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- 3 generations backK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
- 2 generations backK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- 1 generation backK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
- This deviceK183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low…Neomed, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK210971 EnteraLoc FlowVonco Products · 2021
- Descendant · cites it directly · 0 of its ownK253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable…CMT Health PTE., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK223683 EnteraLoc FlowVonco Products · 2023
- Descendant · cites it directly · 0 of its ownK222155 O-ring gasket syringe with ENFit connector (single use or reusable)…Jiangsu Caina Medical Co.,Ltd · 2022
- Descendant · cites it directly · 0 of its ownK203613 ENFit Reusable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd · 2021
Most influential descendants
Showing 5 of 5 · See all- K210971EnteraLoc FlowVonco Products · 2021 · cites it directly1descendant
- K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…CMT Health PTE., Ltd. · 2026 · cites it directly0descendants
- K223683EnteraLoc FlowVonco Products · 2023 · 2 generations on0descendants
- K222155O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe…Jiangsu Caina Medical Co.,Ltd · 2022 · cites it directly0descendants
- K203613ENFit Reusable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −7 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −6 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| −5 | K100099 | Oral/Enteral Syringes | Philips Children'S Medical Ventures | 2010 | — |
| −4 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| −3 | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
| −2 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible… | Neomed, Inc. | 2015 | — |
| −1 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and… | Neomed, Inc. | 2016 | — |
| 0 (this device) | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip… | Neomed, Inc. | 2019 | — |
| +1 | K210971 | EnteraLoc Flow | Vonco Products | 2021 | — |
| +1 | K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral… | CMT Health PTE., Ltd. | 2026 | — |
| +2 | K223683 | EnteraLoc Flow | Vonco Products | 2023 | — |
| +1 | K222155 | O-ring gasket syringe with ENFit connector (single use or reusable)… | Jiangsu Caina Medical Co.,Ltd | 2022 | — |
| +1 | K203613 | ENFit Reusable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 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? (1)
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 |
|---|---|---|---|
| * | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Summary page 4…ode : PNR PREDICATE DEVICE Oral/Enteral Syringes with ENFit™ connector (12 mL to 100 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit™ connector (0.5 mL to 6 mL) (K161039) Predicate device has not been subject to a design-related recall. DEVICE DESCRIPTION NeoMed Oral/Enteral Syringes with ENFit®… | 2016 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 39 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K210971 (Vonco Products, 2021) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K161039.
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. 2019, 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?
Single Use Oral/Enteral Syringes with ENFit Connector (provided sterile and non-sterile): The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical and non-clinical settings by users ranging from clinicians to laypersons in all age groups. Reusable Oral/Enteral Syringes with ENFit Connector (provided non-sterile)…
Read the full statement (130 words)
Single Use Oral/Enteral Syringes with ENFit Connector (provided sterile and non-sterile):
The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical and non-clinical settings by users ranging from clinicians to laypersons in all age groups.
Reusable Oral/Enteral Syringes with ENFit Connector (provided non-sterile):
The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.
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/K183540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183540: Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183540
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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