510(k) · Cleared
ClearedNeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
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 Jun 17, 2016 as substantially equivalent to K152857 (Neomed, Inc., 2015) after a 65-day review. Its family tree reaches back 7 generations to 1980. 1 of the 41 devices in its family, counting itself, has a Class I recall. 21 later devices descend from it.
- Decided
- Jun 17, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- PNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K801558 (1980). 19 ancestors in all. 21 later devices descend from it, 10 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 6 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 5 generations backK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- 4 generations backK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
- 3 generations backK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- 2 generations backK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
- 1 generation backK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- This deviceK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low…Neomed, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK161979 ENFit enteral syringeJiangyin Caina Technology Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK211025 Oral/Enteral Syringe with ENFit connectorNingbo Tianyi Medical Appliance Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK210971 EnteraLoc FlowVonco Products · 2021
- Descendant · 2 generations on · 1 of its ownK193657 Disposable Enteral Feeding Syringe with Enfit ConnectorShinva Ande Healthcare Apparatus Co., Ltd. · 2020
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190502 ENFit Oral / Enteral Syringecites it directly · 2019
Most influential descendants
Showing 5 of 21 · See all- K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…Neomed, Inc. · 2019 · cites it directly5descendants
- K161979ENFit enteral syringeJiangyin Caina Technology Co., Ltd. · 2017 · cites it directly3descendants
- K211025Oral/Enteral Syringe with ENFit connectorNingbo Tianyi Medical Appliance Co., Ltd. · 2021 · cites it directly2descendants
- K210971EnteraLoc FlowVonco Products · 2021 · 2 generations on1descendant
- K193657Disposable Enteral Feeding Syringe with Enfit ConnectorShinva Ande Healthcare Apparatus Co., Ltd. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −6 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −5 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| −4 | K100099 | Oral/Enteral Syringes | Philips Children'S Medical Ventures | 2010 | — |
| −3 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| −2 | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
| −1 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible… | Neomed, Inc. | 2015 | — |
| 0 (this device) | 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 | — |
| +1 | K161979 | ENFit enteral syringe | Jiangyin Caina Technology Co., Ltd. | 2017 | — |
| +1 | K211025 | Oral/Enteral Syringe with ENFit connector | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021 | — |
| +2 | K210971 | EnteraLoc Flow | Vonco Products | 2021 | — |
| +2 | K193657 | Disposable Enteral Feeding Syringe with Enfit Connector | Shinva Ande Healthcare Apparatus Co., Ltd. | 2020 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 1 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsSummary page 4…Product Code : PNR III. PREDICATE DEVICE NeoMed NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps (K152857) Predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION NeoMed Oral/Enteral… | 2015 |
What descends from it? (21)
See all 2110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral… | 2019 | 5 |
| K161979 | ENFit enteral syringe | 2017 | 3 |
| K211025 | Oral/Enteral Syringe with ENFit connector | 2021 | 2 |
| K182649 | Enteral Feeding Syringes with Enfit Connectors | 2018 | 1 |
| K200557 | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) | 2020 | 0 |
| K190502 | ENFit Oral / Enteral Syringe Class I | 2019 | 0 |
| K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | 2018 | 0 |
| K170371 | DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3… | 2017 | 0 |
| K160855 | U&U Enteral Syringe | 2016 | 0 |
| K162188 | Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low… | 2016 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K183540 (Neomed, Inc., 2019) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K152857.
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. 2016, 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 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 or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161039: NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161039
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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