510(k) · Cleared
ClearedFidmi Low Profile Enteral Feeding Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fidmi Medical, Ltd. · KGC Tube, Gastro-Enterostomy
Cleared on Sep 30, 2019 as substantially equivalent to K161003 (Boston Scientific Corporation, 2016) after an 83-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Sep 30, 2019
- Review
- 83 days
- Class
- Class II
- Product code
- KGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910584 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK910584 One Step Button (TM)Applied Medical Technologies · 1991 · Recalled
- 1 generation backK161003 EndoVive One Step Button Low Profile Initial Placement PEG Kit with…Boston Scientific Corporation · 2016 · Recalled
- This deviceK191844 Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910584 | One Step Button (TM) | Applied Medical Technologies | 1991 | 6 |
| −1 | K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit… | Boston Scientific Corporation | 2016 | 1 |
| 0 (this device) | K191844 | Fidmi Low Profile Enteral Feeding Device | Fidmi Medical, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2002 | 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 KGC? 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 KGC device
- #1 K242211 PUMA-G Pediatric Systemscore 10.5 · 5 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 |
|---|---|---|---|
| * | K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector…Summary page 4…Scientific Corporation “One Step Button, Low Profile Initial Placement PEG Kit” and the Low Profile Button Replacement Gastrostomy Tube Kit cleared under K161003 4. REFERENCE DEVICE • Kimberly-Clark MIC-KEY “Low Profile Gastrostomy Tube and Accessories” cleared under… | 2016 |
| † | K122653 | Mic-Key SF Low Profile Gastrostomy Tube and Accessories | 2013 |
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 28 years and passes through 3 companies; a new generation was cleared every 25.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KGC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGC
159in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGC
106in 2025
MAUDE reports naming product code KGC, 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 | 12 |
| 2008 | 2 | — | 0 | 30 |
| 2009 | 1 | — | 5 | 47 |
| 2010 | 0 | — | 6 | 67 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 41 |
| 2015 | 0 | — | 1 | 72 |
| 2016 | 0 | — | 0 | 69 |
| 2017 | 1 | — | 0 | 102 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 3 | 159 | 0 | 90 |
| 2020 | 1 | — | 0 | 118 |
| 2021 | 0 | — | 0 | 73 |
| 2022 | 0 | — | 0 | 51 |
| 2023 | 1 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 87 |
| 2025 | 1 | — | 0 | 106 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Fidmi Low Profile Enteral Feeding Device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means. Fidmi Low Profile Enteral Feeding Device Measuring kit is indicated for measuring the length of the stoma prior to placement of a low-profile feeding tube. The Fidmi Low Profile Enteral Feeding Device Replaceable Tube is intended…
Read the full statement (124 words)
The Fidmi Low Profile Enteral Feeding Device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
Fidmi Low Profile Enteral Feeding Device Measuring kit is indicated for measuring the length of the stoma prior to placement of a low-profile feeding tube.
The Fidmi Low Profile Enteral Feeding Device Replaceable Tube is intended for use only with the Fidmi Low Profile Enteral Feeding Device, for the replacement of an existing tube. It is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
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/K191844 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191844: Fidmi Low Profile Enteral Feeding Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191844
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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