510(k) · Cleared
ClearedEnteral Feeding Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kb Medical (Group), Inc. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Nov 16, 2021 as substantially equivalent to K142539 (Zevex, Inc., 2015) after a 238-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Nov 16, 2021
- Review
- 238 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K851539 (1985). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK851539 Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co. · 1985
- 3 generations backK954735 EnteraliteZevex Intl., Inc. · 1996
- 2 generations backK012147 Device Modification of Enteral Feeding Sets for Gravity and Pump UseZevex, Inc. · 2001
- 1 generation backK142539 EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral…Zevex, Inc. · 2015 · Recalled
- This deviceK210854 Enteral Feeding SetKb Medical (Group), Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap Clo | Chesebrough-Pond'S U.S.A. Co. | 1985 | — |
| −3 | K954735 | Enteralite | Zevex Intl., Inc. | 1996 | — |
| −2 | K012147 | Device Modification of Enteral Feeding Sets for Gravity and Pump Use | Zevex, Inc. | 2001 | — |
| −1 | K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding… | Zevex, Inc. | 2015 | 1 |
| 0 (this device) | K210854 | Enteral Feeding Set | Kb Medical (Group), Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 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 |
|---|---|---|---|
| * | K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery SetSummary page 6…r and 7) protecting cover. The difference between the 5 models is the specification of bag and tube. 5. Identification of Predicate Device 510(k) Number: K142539 Product Name: Enteralite Infinity Enteral Pump Delivery Set, 1200 ML Enteral Feeding Delivery Set (Sele… | 2015 |
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 36 years and passes through 4 companies; a new generation was cleared every 10.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K142539.
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. 2021, 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?
Enteral feeding set is intended to use gravity to deliver liquid nutritional formulas or water to patient’s enteral access device (feeding tube). The device includes a bag to contain the feeding solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210854 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210854: Enteral Feeding Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210854
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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