510(k) Report

510(k) · Cleared

Cleared

IBAG

K110518510(k) TraditionalCleared Jun 24, 2011121-day reviewClass II21 CFR 876.5250

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

Future Path Medical, LLC · KNX Collector, Urine, (And Accessories) For Indwelling Catheter

Cleared on Jun 24, 2011 as substantially equivalent to K924436 (C.R. Bard, Inc., 1994) after a 121-day review. Its family tree reaches back 1 generation to 1994.

Decided
Jun 24, 2011
Review
121 days
Class
Class II
Product code
KNX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K924436 (1994). No later device cites it as a predicate yet.

K924436 · Bard Urotrack II Monitoring · C.R. Bard, Inc. · 199419901995200020052010
K924436 · Bard Urotrack II Monitoring · C.R. Bard, Inc. · 19940
  1. Root · 1 generation backK924436 Bard Urotrack II MonitoringC.R. Bard, Inc. · 1994
  2. This deviceK110518 IBAGFuture Path Medical, LLC · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K924436Bard Urotrack II MonitoringC.R. Bard, Inc.1994—
0 (this device)K110518IBAGFuture Path Medical, LLC2011—
FIG. 1 — Lineage of K110518, 1994–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 KNX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K924436Bard Urotrack II Monitoring
Summary page 1
…e: EXS Submission Type: 510(K) Exempt subject to 21CFR876.9 Regulation Number: 876.1800 Device Class: 2 2. Equivalent legally marketed devices: BARD CritiCore (K924436) Bard Urological 510(k): UROTRACK 11 Monitoring System 3. Indications for Use (intended use). This device is intended to meas…
C.R. Bard, Inc.1994—

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?

  • Its one ancestor has no recall.

How does its category compare?

All KNX devices

KNX Collector, Urine, (And Accessories) For Indwelling Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KNX

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNX

Too few KNX 510(k)s in any year since 2007 to give a median.

Recalls per year · KNX

1in 2023

2011: 32016: 12023: 1, 1 Class I2026 (partial year): 2
2007high 3 (2011) · low 0 (2007)2026

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

Adverse event reports per year · KNX

196in 2025

2007: 12008: 32009: 42010: 112011: 72012: 162013: 42014: 152015: 212016: 822017: 1542018: 1902019: 2352020: 2152021: 2092022: 1672023: 1782024: 1622025: 196
2007high 235 (2019) · low 1 (2007)2025

MAUDE reports naming product code KNX, 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
20070—01
20080—03
20090—04
20100—011
20111—37
20120—016
20130—04
20140—015
20150—021
20160—182
20170—0154
20180—0190
20190—0235
20200—0215
20210—0209
20220—0167
20230—1 (1)178
20240—0162
20250—0196
20260—2—

What is it indicated for?

This device is intended to measure/display collected urine volume. It detects fill level and temperature.

Indications for use as stated in the FDA summary.

Recent decisions in KNX

The KNX category page

  • K9733644L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage BagMaersk Medical A/S · 1998
  • K972887Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg BagMedline Industries, Inc. · 1997
  • K971271Besecure External Urinary Collection SystemUrology Research Intl., Inc. · 1997
  • K971929Amsino Urinary Leg BagAmsino Intl., Inc. · 1997
  • K971764Welcon Hue-VU Urinary Drainage BagWelcon, Inc. · 1997

https://510kreport.com/device/K110518 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110518: IBAG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110518

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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