510(k) · Cleared
ClearedPUMA-G 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 Mar 29, 2023 as substantially equivalent to K183057 (Coaptech, LLC, 2019) after a 90-day review. Its family tree reaches back 4 generations to 1985. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Mar 29, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- KGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K852363 (1985). 6 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK852363 Mic Gastrostomy Tube Percutaneous Insertion KitMedical Innovations Corp. · 1985
- 3 generations backK080253 Kimberly-Clark Introducer KitsKimberly-Clark Corp. · 2008
- 2 generations backK093312 Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy…Kimberly-Clark Corp. · 2009
- 1 generation backK183057 PUMA-G SystemCoaptech, LLC · 2019
- This deviceK223916 PUMA-G SystemCoaptech, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK242211 PUMA-G Pediatric SystemCoaptech, Inc. · 2025
Class I recalls in this family
- K921370 Mic Gastro-Enterostomy Tube Modification4 generations back · 1994
Most influential descendants
Showing 1 of 1 · See all- K242211PUMA-G Pediatric SystemCoaptech, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852363 | Mic Gastrostomy Tube Percutaneous Insertion Kit | Medical Innovations Corp. | 1985 | — |
| −3 | K080253 | Kimberly-Clark Introducer Kits | Kimberly-Clark Corp. | 2008 | — |
| −2 | K093312 | Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal… | Kimberly-Clark Corp. | 2009 | — |
| −1 | K183057 | PUMA-G System | Coaptech, LLC | 2019 | — |
| 0 (this device) | K223916 | PUMA-G System | Coaptech, Inc. | 2023 | — |
| +1 | K242211 | PUMA-G Pediatric System | Coaptech, Inc. | 2025 | — |
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 |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K183057 | PUMA-G SystemSummary page 4…ries 21 CFR 876.5980 (Product Code KGC) Predicate Device Information Device Name PUMA-G System K Number K183057 Device Description The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes,… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242211 | PUMA-G Pediatric System | 2025 | 0 |
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 · 4 generations back · ◆ in the 1994 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 38 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K242211 (Coaptech, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall
facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults and adolescents of
sufficient size (“Transitional Adolescent B” patients 18 to 21 years of age with no special considerations
compared to adults).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223916 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223916: PUMA-G System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223916
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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