510(k) · Cleared
ClearedFeeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anhui Tiankang Medical Technology Co., Ltd. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Aug 17, 2023 as substantially equivalent to K210598 (Cair Lgl, 2021) after a 337-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- Aug 17, 2023
- Review
- 337 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K820441 (1982). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK820441 Argyle PVC Feeding TubeSherwood Medical Co. · 1982
- 2 generations backK150084 Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU)…Covidien · 2015
- 1 generation backK210598 Pediatric Nasogastric Feeding Tubes - Single ENFit PortCair Lgl · 2021
- This deviceK222773 Feeding TubeAnhui Tiankang Medical Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K820441 | Argyle PVC Feeding Tube | Sherwood Medical Co. | 1982 | — |
| −2 | K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and… | Covidien | 2015 | — |
| −1 | K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | Cair Lgl | 2021 | — |
| 0 (this device) | K222773 | Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 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 |
|---|---|---|---|
| * | K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit PortSummary page 4…gle ENFit Port Regulation name: Gastrointestinal tube and accessories Classification: Class II Product Code: PIF Premarket Notification: K210598 Manufacturer: Cair Lgl IV Device description The Feeding Tube consists of the following main components: a feeding t… | 2021 |
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 41 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2023, 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?
This product is intended for use in neonatal and pediatric patients to provide nutrition via nasal or orogastric placement. The Polyurethane Feeding Tube is not intended for use beyond 30 days. The PVC Feeding Tube is not intended for use beyond 24h
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222773: Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222773
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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