510(k) · Cleared
ClearedENFit Adaptor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Caina Medical Co.,Ltd · PIO Enteral Specific Transition Connectors
Cleared on Jan 18, 2024 as substantially equivalent to K140581 (Cedic S.R.L., 2014) after a 112-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jan 18, 2024
- Review
- 112 days
- Class
- Class II
- Product code
- PIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940556 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK940556 Sandoz Nutrition Compat (R) Enteral Feeding PumpSandoz Nutrition · 1994 · Recalled
- 2 generations backK080340 Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing…Novartis Nutrition Corp. · 2008
- 1 generation backK140581 Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral…Cedic S.R.L. · 2014
- This deviceK233190 ENFit AdaptorJiangsu Caina Medical Co.,Ltd · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940556 | Sandoz Nutrition Compat (R) Enteral Feeding Pump | Sandoz Nutrition | 1994 | 2 |
| −2 | K080340 | Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and… | Novartis Nutrition Corp. | 2008 | — |
| −1 | K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit… | Cedic S.R.L. | 2014 | — |
| 0 (this device) | K233190 | ENFit Adaptor | Jiangsu Caina Medical Co.,Ltd | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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 PIO? 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 PIO device
- #1 K231299 Nutricair enteral ENFit adapter: ENFit male –…score 7.3 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…Summary page 5…life 5 years. No DEHP, BPA and Natural Rubber Latex are added in the device. 6. Identification of Predicate Device Predicate Device 510(k) Number: K140581 Product Name: Cedic Enteral Distal End ENFit Transition Connector 7. Clinical Test Conclusion Not applicable. 8… | 2014 |
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 30 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 6 other devices also cite its predicate K140581.
How does its category compare?
All PIO devicesPIO Enteral Specific Transition Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PIO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PIO
90in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIO
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIO
9in 2025
MAUDE reports naming product code PIO, 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 | 1 | — | 0 | 0 |
| 2015 | 3 | 90 | 0 | 119 |
| 2016 | 1 | — | 0 | 215 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 1 | 6 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 2 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233190: ENFit Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233190
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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