510(k) · Cleared
ClearedNasogastric Feeding Tubes - ENFit Port - PVC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cair Lgl · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Jun 9, 2022 as substantially equivalent to K150084 (Covidien, 2015) after a 252-day review. Its family tree reaches back 2 generations to 1982. 1 later device descends from it.
- Decided
- Jun 9, 2022
- Review
- 252 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K820441 (1982). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK820441 Argyle PVC Feeding TubeSherwood Medical Co. · 1982
- 1 generation backK150084 Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU)…Covidien · 2015
- This deviceK213258 Nasogastric Feeding Tubes - ENFit Port - PVCCair Lgl · 2022
- Descendant · cites it directly · 0 of its ownK233974 Mucosal Impedance Measurement SystemAlandra Medical Sapi DE CV · 2024
Most influential descendants
Showing 1 of 1 · See all- K233974Mucosal Impedance Measurement SystemAlandra Medical Sapi DE CV · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820441 | Argyle PVC Feeding Tube | Sherwood Medical Co. | 1982 | — |
| −1 | K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and… | Covidien | 2015 | — |
| 0 (this device) | K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | 2022 | — |
| +1 | K233974 | Mucosal Impedance Measurement System | Alandra Medical Sapi DE CV | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric…Summary page 4…™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector 510(k) Number: K150084 Manufacturer: Covidien Product Code: PIF Device Class: Class II Cair LGL… | 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 |
|---|---|---|---|
| K233974 | Mucosal Impedance Measurement System | 2024 | 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 40 years and passes through 3 companies; a new generation was cleared every 33.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K233974 (Alandra Medical Sapi DE CV, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K150084.
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. 2022, 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 Nasogastric Feeding Tubes - ENFit Port - PVC are intended for enteral feeding to deliver nutrition, fluids, and medications to the patient from an enteral feeding syringe or feeding set designed with ENFit connectors for enteral applications.
This product is single use for no longer than 24 hours.
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/K213258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213258: Nasogastric Feeding Tubes - ENFit Port - PVC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213258
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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