510(k) · Cleared
Recalled · Class III · 2018Medela Low Dose Enteral Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela, Inc. · PNR Enteral Syringes With Enteral Specific Connectors
Cleared on Feb 15, 2017 as substantially equivalent to K161963 (Covidien, 2016) after a 229-day review. Its family tree reaches back 9 generations to 1980. It has been recalled once.
- Decided
- Feb 15, 2017
- Review
- 229 days
- Class
- Class II
- Product code
- PNR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K801558 (1980). 22 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 deviceK161811 Medela Low Dose Enteral SyringeMedela, Inc. · 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 deviceK161811 Medela Low Dose Enteral SyringeMedela, Inc. · 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) | K161811 | Medela Low Dose Enteral Syringe | Medela, Inc. | 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 | 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 |
|---|---|---|---|
| * | K161963 | Monoject Enteral Syringe with ENFit Connector Cleared while this submission was under review Summary page 4…Enteral Syringes with Enteral Specific Connectors DEVICE CLASSIFICATION: Class Il PrRobpuCT CODE PNR PREDICATE DEVICES: Monoject™ Enteral Syringe with ENFit Connector (K161963) Substantially Equivalent To: The Medela Low Dose Enteral Syringe is substantially equivalent in intended use, principal of ope… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2018 | Class III | Z-2061-2019 | Equipment maintenance | The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact. |
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 22 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 Medela Low Dose Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids enterally, into the gastrointestinal system of patients in all age groups. The enteral syringes are intended to be used in clinical settings by clinicians.
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/K161811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161811: Medela Low Dose Enteral Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161811
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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