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FDA product code · Gastroenterology, Urology

KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product code KNX covers Collector, Urine, (And Accessories) For Indwelling Catheter, a Class II device regulated under 21 CFR 876.5250. FDA has cleared 206 devices in this code. Median review time across the 206 most recent decisions is 45 days. openFDA lists 19 recall records against this code.

Updated · ingest status · JSON

Class
Class II
Regulation
21 CFR 876.5250
Review panel
Gastroenterology, Urology
Clearances
206

What is happening in KNX right now?

KNX (Collector, Urine, (And Accessories) For Indwelling Catheter): nothing changed in the six FDA sources we watch.

Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.

How many devices has FDA cleared in KNX?

FDA has cleared 206 devices under product code KNX since the 510(k) programme began in 1976.

Source: openFDA device/510k · retrieved

Most recent 510(k) clearances in KNX, newest first.
510(k)DeviceApplicantDecision
K110518IBAGFuture Path Medical, LLC
K9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/S
K972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.
K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.
K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.
K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.
K964690LIBERTY VALVECleveland Medical Devices, Inc.
K964745AMSINO URINARY DRAINAGE BAGAmsino Intl., Inc.
K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)Customed, Inc.
K960949PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167Bristol-Myers Squibb

How long does FDA review take for KNX?

The median FDA review time for KNX is 45 days, measured across the 206 most recent decisions with both a received date and a decision date.

Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Are there recalls in KNX?

openFDA lists 19 recall records against product code KNX. A recall record covers one firm's corrective action and may span many device lots.

  • Z-1046-2024Open, ClassifiedCardinal Health 200, LLC

    Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

  • Z-1974-2019TerminatedTeleflex Medical

    The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.

  • Z-1975-2019TerminatedTeleflex Medical

    The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.

  • Z-2872-2017TerminatedC.R. Bard, Inc.

    Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.

  • Z-0967-2017TerminatedC.R. Bard, Inc.

    The product contained a latex catheter instead of a silicone catheter.

Showing the 5 most recently initiated of 19. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.

Source: openFDA device/recall · retrieved

How many adverse events are reported for KNX?

MAUDE holds 528 adverse-event reports naming product code KNX, 119 of them received in the last 12 months.

MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.

Source: openFDA device/event · retrieved

Is adverse-event reporting in KNX unusual?

Every month with enough history behind it falls inside KNX's own expected range. Nothing here is unusual for this code.

Monthly adverse-event reports naming KNX, against the expected range computed from this code's own history. Shaded band is the expected range; a bar above it is the month flagged. Retrieved 11 August 2026.
Reports received per month for KNX, with the expected range and whether the month fell outside it.
MonthReportsExpectedVerdict
8Insufficient historyNo expected range — too little history
10Insufficient historyNo expected range — too little history
22Insufficient historyNo expected range — too little history
19Insufficient historyNo expected range — too little history
22Insufficient historyNo expected range — too little history
20Insufficient historyNo expected range — too little history
10Insufficient historyNo expected range — too little history
10Insufficient historyNo expected range — too little history
4Insufficient historyNo expected range — too little history
7Insufficient historyNo expected range — too little history
17Insufficient historyNo expected range — too little history
7Insufficient historyNo expected range — too little history
11Insufficient historyNo expected range — too little history
12Insufficient historyNo expected range — too little history
11Insufficient historyNo expected range — too little history
20Insufficient historyNo expected range — too little history
18Insufficient historyNo expected range — too little history
13Insufficient historyNo expected range — too little history
9Insufficient historyNo expected range — too little history
14Insufficient historyNo expected range — too little history
23Insufficient historyNo expected range — too little history
86–23Within expected (6–23)
104–18Within expected (4–18)
154–20Within expected (4–20)
186–21Within expected (6–21)
136–21Within expected (6–21)
186–22Within expected (6–22)
3112–37Within expected (12–37)
1910–30Within expected (10–30)
1810–31Within expected (10–31)
149–30Within expected (9–30)
178–25Within expected (8–25)
139–27Within expected (9–27)
149–29Within expected (9–29)
177–23Within expected (7–23)
119–25Within expected (9–25)

21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in KNX.

What are the predicate devices in KNX?

FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.

A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.

Who files 510(k)s in KNX?

Across the 206 most recent decisions, these applicants filed most often in KNX.

Most frequent applicants in KNX among recent decisions.
ApplicantRecent clearances
Bio D Corp.9
Conphar, Inc.6
The Kendal Co.6
Coloplast A/S5
Concord Laboratories, Inc.5

Applicant names above are exactly as FDA published them, so one company can appear under several spellings.

Source: openFDA device/510k · retrieved

Watch KNX

Get an email the morning anything changes in KNX — a new clearance, a recall, or an adverse-event spike above this code's own baseline.

Start watching KNX

Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.