510(k) · Cleared
ClearedEnteral Drainage System, Enteral Medicine straw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
HMC Premedical S.p.A. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Jun 18, 2025 as substantially equivalent to K142012 (Corpak Medsystems, 2014) and 1 other predicate after a 267-day review. Its family tree reaches back 3 generations to 2014.
- Decided
- Jun 18, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K132424 (2014). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK132424 MetrixcareThe Metrix Company · 2014
- 2 generations backK170555 U Deliver Bolink ENFit Enteral Feeding SetsU Deliver Medical, LLC · 2017
- 1 generation backK190310 U Deliver Bolink ENFit Enteral Feeding SetsU Deliver Medical, LLC · 2019
- This deviceK242917 Enteral Drainage System, Enteral Medicine strawHMC Premedical S.p.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K132424 | Metrixcare | The Metrix Company | 2014 | — |
| −2 | K170555 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC | 2017 | — |
| −1 | K190310 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC | 2019 | — |
| 0 (this device) | K242917 | Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.p.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K142012 | Farrell Valve System with Equilibrium Technology and Enfit Enteral ConnectorsSummary page 5…R 876.5980 Product Code(s) PIF | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K142012 Farrell Valve System with Equilibrium Technology and Enfit Entggl | PIF K190310 U Deliver Bolink ENFit Enteral Feeding Sets PIF D… | 2014 |
| * | K190310 | U Deliver Bolink ENFit Enteral Feeding SetsSummary page 5…2(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K142012 Farrell Valve System with Equilibrium Technology and Enfit Entggl | PIF K190310 U Deliver Bolink ENFit Enteral Feeding Sets PIF Device Description Summary 21 CFR 807.92(a)(4) The Enteral Drainage System and t… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 4 ancestors has a recall.
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. 2025, 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 Enteral Drainage System is intended to allow the evacuation of excess gas and drainage of
gastrointestinal fluids from patients utilizing an enteral device.
The Enteral Medicine Straw is intended for drawing and delivery of medicine to patients through an
ENFit syringe.
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/K242917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242917: Enteral Drainage System, Enteral Medicine straw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242917
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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