510(k) · Cleared
ClearedPUMA-G Pediatric System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coaptech, Inc. · KGC Tube, Gastro-Enterostomy
Cleared on Apr 29, 2025 as substantially equivalent to K223916 (Coaptech, Inc., 2023) after a 274-day review. Its family tree reaches back 5 generations to 1985. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 29, 2025
- Review
- 274 days
- Class
- Class II
- Product code
- KGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K852363 (1985). 7 ancestors in all. No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK852363 Mic Gastrostomy Tube Percutaneous Insertion KitMedical Innovations Corp. · 1985
- 4 generations backK080253 Kimberly-Clark Introducer KitsKimberly-Clark Corp. · 2008
- 3 generations backK093312 Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy…Kimberly-Clark Corp. · 2009
- 2 generations backK183057 PUMA-G SystemCoaptech, LLC · 2019
- 1 generation backK223916 PUMA-G SystemCoaptech, Inc. · 2023
- This deviceK242211 PUMA-G Pediatric SystemCoaptech, Inc. · 2025
Class I recalls in this family
- K921370 Mic Gastro-Enterostomy Tube Modification5 generations back · 1994
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K852363 | Mic Gastrostomy Tube Percutaneous Insertion Kit | Medical Innovations Corp. | 1985 | — |
| −4 | K080253 | Kimberly-Clark Introducer Kits | Kimberly-Clark Corp. | 2008 | — |
| −3 | K093312 | Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal… | Kimberly-Clark Corp. | 2009 | — |
| −2 | K183057 | PUMA-G System | Coaptech, LLC | 2019 | — |
| −1 | K223916 | PUMA-G System | Coaptech, Inc. | 2023 | — |
| 0 (this device) | K242211 | PUMA-G Pediatric System | Coaptech, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 1 |
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 K223916 PUMA-G Systemscore 9.0 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K223916 | PUMA-G SystemSummary page 5…980 Product Code KGC Regulatory Class II Predicate Device Information Device Name PUMA-G System K Number K223916 Device Description The PUMA-G Pediatric System is a medical device designed to aid in the initial placement of permanent feedi… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 5 generations back · ◆ in the 1994 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 40 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 7 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use.
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/K242211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242211: PUMA-G Pediatric System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242211
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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