510(k) · Cleared
ClearedBD Univia RightFit Enteral Extension Sets and Transitional Adapters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mps Medical, Inc. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Jul 30, 2020 as substantially equivalent to K180236 (Vr Medical Technology Co., Ltd., 2019) after a 197-day review. Its family tree reaches back 6 generations to 1980.
- Decided
- Jul 30, 2020
- Review
- 197 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K801558 (1980). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 5 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 4 generations backK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- 3 generations backK100288 Neomed Enteral Only Extension SetNeomed, Inc. · 2010 · Recalled
- 2 generations backK120272 Ameritus Medical Enteral Feeding Extension SetKentec Medical, Inc. · 2012
- 1 generation backK180236 VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. · 2019
- This deviceK200082 BD Univia RightFit Enteral Extension Sets and Transitional AdaptersMps Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −5 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −4 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| −3 | K100288 | Neomed Enteral Only Extension Set | Neomed, Inc. | 2010 | 1 |
| −2 | K120272 | Ameritus Medical Enteral Feeding Extension Set | Kentec Medical, Inc. | 2012 | — |
| −1 | K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | Vr Medical Technology Co., Ltd. | 2019 | — |
| 0 (this device) | K200082 | BD Univia RightFit Enteral Extension Sets and Transitional Adapters | Mps Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 3 | 0 |
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Summary page 4…gulatory Class: Class II Product Code: PIF, PIO Predicate Device: VR Medical Feeding Tube (510(k) K180236) Reference Device: Neomed Enteral Extension Set (510(k) K100288) Device Description:… | 2019 |
| † | K100288 | Neomed Enteral Only Extension Set | 2010 |
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 40 years and passes through 7 companies; a new generation was cleared every 6.9 years on median.
- 5 of the 19 ancestors have 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. 2020, 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?
BD UniVia™ RightFit enteral extension set is indicated for use in neonatal, pediatric and adult patients in connection with nasogastric/orogastric enteral feeding tube to provide nutrition via nasal or oral gastric tube placements.
BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniVia™ RightFit enteral systems.
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/K200082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200082: BD Univia RightFit Enteral Extension Sets and Transitional Adapters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200082
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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