510(k) · Cleared
ClearedMTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe (with and Without Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Technologies of Georgia, Inc. · KOD Catheter, Urological
Cleared on Jul 17, 2008 as substantially equivalent to K032710 (Apogee Medical, Inc., 2004) after a 108-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jul 17, 2008
- Review
- 108 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973120 (1998). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK973120 Readycath CatheterMedical Technologies of Georgia · 1998
- 2 generations backK013483 Incare Advance; Intermittent Catheter, Plus Intermittent Catheter…Hollister, Inc. · 2002
- 1 generation backK032710 Closed System Intermittent Catheterization KitApogee Medical, Inc. · 2004
- This deviceK080878 MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe…Medical Technologies of Georgia, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973120 | Readycath Catheter | Medical Technologies of Georgia | 1998 | — |
| −2 | K013483 | Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit | Hollister, Inc. | 2002 | — |
| −1 | K032710 | Closed System Intermittent Catheterization Kit | Apogee Medical, Inc. | 2004 | — |
| 0 (this device) | K080878 | MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe (with and… | Medical Technologies of Georgia, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 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 KOD? 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · 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 |
|---|---|---|---|
| * | K032710 | Closed System Intermittent Catheterization KitSummary page 1…JUL 1 7 2008 17.2 Device Name MTG Instant Cath TM MTG Instant Cath Tm Deluxe 17.3 Identification of Predicate or Legally Marketed Device Apogee Closed System Catheter K032710 17.4 Device Description The MTG Instant CathTM is a sterile, closed system, single use, disposable, pre-lubricated PVC or Red R… | 2004 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K032710.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KOD
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
MAUDE reports naming product code KOD, 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 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
MTG Instant Cath, MTG Instant Cath kit, MTG Instant Cath Deluxe and MTG Instant Cath Deluxe kit are intended to be used to drain urine from the patient's bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080878: MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe (with and Without Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080878
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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