510(k) Report

510(k) · Cleared

Cleared

Readycath Catheter

K973120510(k) TraditionalCleared Feb 25, 1998189-day reviewClass II21 CFR 876.5130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Technologies of Georgia · GBM Catheter, Urethral

Cleared on Feb 25, 1998 after a 189-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 21 later devices descend from it.

Decided
Feb 25, 1998
Review
189 days
Class
Class II
Product code
GBM
Recalls
None
Predicates
0

21 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2011: 1 descendant cleared2004: 2 descendants cleared2009: 1 descendant cleared2016: 1 descendant cleared2008: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2018: 2 descendants cleared2015: 2 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK973120 Readycath CatheterMedical Technologies of Georgia · 1998
  2. Descendant · cites it directly · 20 of its ownK013483 Incare Advance; Intermittent Catheter, Plus Intermittent Catheter…Hollister, Inc. · 2002
  3. Descendant · 2 generations on · 15 of its ownK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
  4. Descendant · 2 generations on · 14 of its ownK110862 Vapro Plus Intermittent CatheterHollister Incorporated · 2011
  5. Descendant · 3 generations on · 13 of its ownK141642 Vapro Intermittent CatheterHollister Incorporated · 2014
  6. Descendant · 4 generations on · 6 of its ownK180824 VaPro 2 Intermittent CatheterHollister Incorporated · 2018

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2002: 12004: 22008: 12009: 12011: 12014: 12015: 22016: 12017: 12018: 22019: 22022: 32024: 12025: 12026: 1
2002high 3 (2022) · low 0 (2003)2026

Most influential descendants

Showing 5 of 21 · See all
  • K013483Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitHollister, Inc. · 2002 · cites it directly20descendants
  • K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc. · 2009 · 2 generations on15descendants
  • K110862Vapro Plus Intermittent CatheterHollister Incorporated · 2011 · 2 generations on14descendants
  • K141642Vapro Intermittent CatheterHollister Incorporated · 2014 · 3 generations on13descendants
  • K180824VaPro 2 Intermittent CatheterHollister Incorporated · 2018 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973120Readycath CatheterMedical Technologies of Georgia1998—
+1K013483Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitHollister, Inc.2002—
+2K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064…Hollister, Inc.2009—
+2K110862Vapro Plus Intermittent CatheterHollister Incorporated2011—
+3K141642Vapro Intermittent CatheterHollister Incorporated2014—
+4K180824VaPro 2 Intermittent CatheterHollister Incorporated2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200420
200810
200910
201110
201410
201520
201610
201710
201820
201920
202230
202410
202510
202610
FIG. 1 — Lineage of K973120, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GBM? 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 GBM device

  1. #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (21)

See all 21

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013483Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitHollister, Inc.200220

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?

  • Of its descendants, K013483 (Hollister, Inc., 2002) has gone furthest, with 20 descendants of its own.

How does its category compare?

All GBM devices

GBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBM

1in 2025

2007: 22009: 12011: 22012: 32014: 12015: 52016: 32017: 22018: 62019: 72020: 62022: 22025: 1
2007high 7 (2019) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GBM

230in 2020

2012: 139 days median2015: 76 days median2016: 112 days median2018: 93 days median2019: 121 days median2020: 230 days median
2007high 230 (2020) · low 76 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GBM

1in 2025

2008: 52011: 12023: 1, 1 Class I2025: 12026 (partial year): 1
2007high 5 (2008) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GBM

311in 2025

2007: 52008: 182009: 32010: 332011: 462012: 322013: 412014: 192015: 212016: 492017: 592018: 822019: 1482020: 1442021: 1022022: 2832023: 2022024: 4682025: 311
2007high 468 (2024) · low 3 (2009)2025

MAUDE reports naming product code GBM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—05
20080—518
20091—03
20100—033
20112—146
20123139032
20130—041
20141—019
2015576021
20163112049
20172—059
2018693082
201971210148
202062300144
20210—0102
20222—0283
20230—1 (1)202
20240—0468
20251—1311
20260—1—

What is it indicated for?

The WG InstantCath Pre-lubricated Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Medical Technologies of Georgia

12 FDA decisions under this applicant name. See the company

  • K952392Mli SetMedical Technologies of Georgia · 1995
  • K911129MMG Bile BagMedical Technologies of Georgia · 1991
  • K873136MMG Cath-N-PlaceMedical Technologies of Georgia · 1987
  • K871949MMG Delee Suction Catheter W/Mucous TrapMedical Technologies of Georgia · 1987
  • K854821MMG External Female CathetersMedical Technologies of Georgia · 1986

Recent decisions in GBM

The GBM category page

  • K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd. · 2025
  • K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited · 2022
  • K211436Intermittent Catheter (Not Finalized)Hollister Incorporated · 20221 recall
  • K200820SpeediCath Compact SetColoplast · 2020
  • K192904SpeediCath Compact SetColoplast · 2020

https://510kreport.com/device/K973120 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973120: Readycath Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973120

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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