510(k) · Cleared
ClearedKangaroo Enteral Feeding Syringes with Enfit Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · PNR Enteral Syringes With Enteral Specific Connectors
Cleared on Feb 23, 2015 as substantially equivalent to K112434 (Bd Medical Surgical, 2011) after a 203-day review. Its family tree reaches back 5 generations to 1980. 1 of the 45 devices in its family, counting itself, has a Class I recall. 31 later devices descend from it.
- Decided
- Feb 23, 2015
- Review
- 203 days
- Class
- Class II
- Product code
- PNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K801558 (1980). 13 ancestors in all. 31 later devices descend from it, 4 citing it directly. 1 of the 45 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 4 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 3 generations backK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- 2 generations backK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
- 1 generation backK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- This deviceK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
- Descendant · cites it directly · 30 of its ownK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- Descendant · 2 generations on · 21 of its ownK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
- Descendant · 3 generations on · 5 of its ownK183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low…Neomed, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK160419 Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien · 2016
- Descendant · 3 generations on · 3 of its ownK161979 ENFit enteral syringeJiangyin Caina Technology Co., Ltd. · 2017
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190502 ENFit Oral / Enteral Syringe3 generations on · 2019
Most influential descendants
Showing 5 of 31 · See all- K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc. · 2015 · cites it directly30descendants
- K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Neomed, Inc. · 2016 · 2 generations on21descendants
- K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…Neomed, Inc. · 2019 · 3 generations on5descendants
- K160419Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien · 2016 · cites it directly4descendants
- K161979ENFit enteral syringeJiangyin Caina Technology Co., Ltd. · 2017 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −4 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −3 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| −2 | K100099 | Oral/Enteral Syringes | Philips Children'S Medical Ventures | 2010 | — |
| −1 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| 0 (this device) | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
| +1 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible… | Neomed, Inc. | 2015 | — |
| +2 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and… | Neomed, Inc. | 2016 | — |
| +3 | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip… | Neomed, Inc. | 2019 | — |
| +1 | K160419 | Monoject Enteral Feeding Syringe with ENFit Connector | Covidien | 2016 | — |
| +3 | K161979 | ENFit enteral syringe | Jiangyin Caina Technology Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 1 |
| 2020 | 3 | 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 |
|---|---|---|---|
| * | K112434 | BD Oral/Enteral Syringe with BD Univia ConnectionSummary page 4…de Name: Kangaroo™ Enteral Feeding Syringe with ENFit Connector c. Identification of Legally Marketed Device(s) BD™ Oral/Enteral Syringe with BD UniVia™ Connection, K112434 d. Device Brief Description The Kangaroo™ Enteral Feeding Syringe with ENFit Connector consists of disposable enteral fee… | 2011 |
What descends from it? (31)
See all 314 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K152857 (Neomed, Inc., 2015) has gone furthest, with 30 descendants of its own.
- 1 other device also cites its predicate K112434.
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. 2015, 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 Kangaroo™ Enteral Feeding Syringe with ENFit Connector delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. The feeding syringes are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians (under the supervision of a clinician), to administer enteral nutrition. The syringe is intended for all age groups.
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/K142128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142128: Kangaroo Enteral Feeding Syringes with Enfit Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142128
Report an extraction error
Are you the manufacturer?
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