510(k) · Cleared
ClearedENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentaferte Italia S.R.L. · PNR Enteral Syringes With Enteral Specific Connectors
Cleared on Mar 22, 2017 as substantially equivalent to K143344 (Neomed, Inc., 2015) and 1 other predicate after a 334-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 22, 2017
- Review
- 334 days
- Class
- Class II
- Product code
- PNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951871 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK951871 Piston SyringeBaxa Corp. · 1995
- 3 generations backK092908 Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO…Neomed, Inc. · 2010
- 2 generations backK122373 Neomed Oral/Enteral SyringeNeomed, Inc. · 2012
- 1 generation backK143344 NeoMed NeoConnect Enteral Syringes with ENFit ConnectorNeomed, Inc. · 2015
- This deviceK161141 ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes…Pentaferte Italia S.R.L. · 2017
- Descendant · cites it directly · 0 of its ownK211661 ENFit enteral syringes (NUTRIFIT)Pentaferte Italia S.R.L. · 2022
- Descendant · cites it directly · 0 of its ownK211593 Enteral Pump SyringeJiangsu Caina Medical Co.,Ltd · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951871 | Piston Syringe | Baxa Corp. | 1995 | — |
| −3 | K092908 | Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO… | Neomed, Inc. | 2010 | — |
| −2 | K122373 | Neomed Oral/Enteral Syringe | Neomed, Inc. | 2012 | — |
| −1 | K143344 | NeoMed NeoConnect Enteral Syringes with ENFit Connector | Neomed, Inc. | 2015 | — |
| 0 (this device) | K161141 | ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT | Pentaferte Italia S.R.L. | 2017 | — |
| +1 | K211661 | ENFit enteral syringes (NUTRIFIT) | Pentaferte Italia S.R.L. | 2022 | — |
| +1 | K211593 | Enteral Pump Syringe | Jiangsu Caina Medical Co.,Ltd | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K143344 | NeoMed NeoConnect Enteral Syringes with ENFit ConnectorSummary page 5…ENFit enteral pump syringes are single use devices. Identification of Predicate Proprietary Name: NeoMed, Inc Device - K143344 Classification Name: Gastrointestinal tube and accessories devices; 21 CFR… | 2015 |
| * | K122373 | Neomed Oral/Enteral SyringeSummary page 5…Classification Name: Gastrointestinal tube and accessories devices; 21 CFR 876.5980 - K122373 Classification Name: Piston Syringe; 21 CFR 880.5560 Registered Esta… | 2012 |
What descends from it? (2)
2 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 22 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K211661 (Pentaferte Italia S.R.L., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143344.
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?
ENFit enteral pump syringes PENTA ENFit TM and ENFit enteral pump syringes NUTRIFIT TM deliver nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump.
ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended for neonatal, pediatric and adult use. ENFit enteral pump syringes are single use devices.
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/K161141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161141: ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161141
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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