510(k) · Cleared
ClearedKimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access Dilation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · KGC Tube, Gastro-Enterostomy
Cleared on Dec 8, 2009 as substantially equivalent to K080253 (Kimberly-Clark Corp., 2008) after a 47-day review. Its family tree reaches back 2 generations to 1985. 1 of the 10 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Dec 8, 2009
- Review
- 47 days
- Class
- Class II
- Product code
- KGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852363 (1985). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK852363 Mic Gastrostomy Tube Percutaneous Insertion KitMedical Innovations Corp. · 1985
- 1 generation backK080253 Kimberly-Clark Introducer KitsKimberly-Clark Corp. · 2008
- This deviceK093312 Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy…Kimberly-Clark Corp. · 2009
- Descendant · cites it directly · 2 of its ownK183057 PUMA-G SystemCoaptech, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK223916 PUMA-G SystemCoaptech, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK170020 Peel-Away Introducer SetCook Incorporated · 2017
- Descendant · 3 generations on · 0 of its ownK242211 PUMA-G Pediatric SystemCoaptech, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK173685 Peel-Away Introducer SetCook Incorporated · 2017
Class I recalls in this family
- K921370 Mic Gastro-Enterostomy Tube Modification2 generations back · 1994
Most influential descendants
Showing 5 of 5 · See all- K183057PUMA-G SystemCoaptech, LLC · 2019 · cites it directly2descendants
- K223916PUMA-G SystemCoaptech, Inc. · 2023 · 2 generations on1descendant
- K170020Peel-Away Introducer SetCook Incorporated · 2017 · cites it directly1descendant
- K242211PUMA-G Pediatric SystemCoaptech, Inc. · 2025 · 3 generations on0descendants
- K173685Peel-Away Introducer SetCook Incorporated · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852363 | Mic Gastrostomy Tube Percutaneous Insertion Kit | Medical Innovations Corp. | 1985 | — |
| −1 | K080253 | Kimberly-Clark Introducer Kits | Kimberly-Clark Corp. | 2008 | — |
| 0 (this device) | K093312 | Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal… | Kimberly-Clark Corp. | 2009 | — |
| +1 | K183057 | PUMA-G System | Coaptech, LLC | 2019 | — |
| +2 | K223916 | PUMA-G System | Coaptech, Inc. | 2023 | — |
| +1 | K170020 | Peel-Away Introducer Set | Cook Incorporated | 2017 | — |
| +3 | K242211 | PUMA-G Pediatric System | Coaptech, Inc. | 2025 | — |
| +2 | K173685 | Peel-Away Introducer Set | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K080253 | Kimberly-Clark Introducer KitsSummary page 1…(21 CFR Part 876.5980, Product Code KGC) Legally Marketed Device to Which Substantial Equivalence is Claimed: 1. Kimberly-Clark Introducer Kits (K080253) Device Description(s): 1. The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy m T-Fasteners consists of an interna… | 2008 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K921370Mic Gastro-Enterostomy Tube ModificationMedical Innovations Corp. · 1994 · 2 generations back · ◆ in the 1994 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 22.5 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K183057 (Coaptech, LLC, 2019) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K080253.
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-PeXyTm T-Fasteners is intended to affix the stomach to the anterior abdominal wail facilitating primary placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these T-Fasteners be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes.
The Kimberly-Clark Enteral Acccess Dilation System is intended to facilitate stoma tract dilation prior to placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these dilator be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093312 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093312: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093312
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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