510(k) · Cleared
ClearedMedline ENFit Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Nov 29, 2016 as substantially equivalent to K142128 (Covidien, 2015) and 1 other predicate after a 267-day review. Its family tree reaches back 7 generations to 1980. 1 later device descends from it.
- Decided
- Nov 29, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K801558 (1980). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK160642 Medline ENFit SyringeMedline Industries, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK202285 Medline ENfit OTC Feeding SyringeMedline Industries, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K202285Medline ENfit OTC Feeding SyringeMedline Industries, Inc. · 2020 · cites it directly0descendants
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) | K160642 | Medline ENFit Syringe | Medline Industries, Inc. | 2016 | — |
| +1 | K202285 | Medline ENfit OTC Feeding Syringe | Medline Industries, Inc. | 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 |
|---|---|---|
| 2020 | 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 PIF? 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 PIF device
- #1 K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi…score 15.5 · 13 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 |
|---|---|---|---|
| * | K142128 | Kangaroo Enteral Feeding Syringes with Enfit ConnectorSummary page 4…ors Regulation Name: Gastrointestinal Tube and Accessories Product Code: PIF Regulatory Class: II Classification Panel: Gastroenterology / Urology Predicate Devices A. K142128 - Covidien Kangaroo™ Enteral Feeding Syringes with ENFit connector B. K152857 - NeoMed NeoConnect™ Enteral Syringes with ENFit™ C… | 2015 |
| * | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsSummary page 4…egulatory Class: II Classification Panel: Gastroenterology / Urology Predicate Devices A. K142128 - Covidien Kangaroo™ Enteral Feeding Syringes with ENFit connector B. K152857 - NeoMed NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202285 | Medline ENfit OTC Feeding Syringe | 2020 | 0 |
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 36 years and passes through 8 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, K202285 (Medline Industries, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K142128.
How does its category compare?
All PIF devicesPIF Gastrointestinal Tubes 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 · PIF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIF
242in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIF
83in 2025
MAUDE reports naming product code PIF, 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 | 3 | 119 | 0 | 0 |
| 2015 | 9 | 143 | 106 | 12 |
| 2016 | 3 | 267 | 0 | 45 |
| 2017 | 5 | 174 | 0 | 17 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 7 | 135 | 0 | 28 |
| 2020 | 4 | 165 | 0 | 70 |
| 2021 | 4 | 242 | 0 | 89 |
| 2022 | 4 | 167 | 0 | 77 |
| 2023 | 4 | 242 | 0 | 96 |
| 2024 | 2 | — | 1 | 110 |
| 2025 | 2 | — | 0 | 83 |
| 2026 | 3 | 239 | 0 | — |
What is it indicated for?
The Medline ENFit Syringe is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) to measure and administer enteral nutrition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160642: Medline ENFit Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160642
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