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Robinson Catheter: Materials, Sizes and FDA Class

What a Robinson catheter is, how FDA records classify it, which Robinson products are latex-labeled, and one sourced size table.

Written and maintained by CASRAI Editorial Board

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This page describes products and general use; it is not medical advice.

A Robinson catheter is a straight, flexible urethral catheter with a rounded closed tip and drainage eyes, sold under the Robinson name by several manufacturers. In U.S. Food and Drug Administration (FDA) records the name is a model or brand name, not a separate device type: Robinson-named products are filed under the urological catheter classification, and they differ in material, including natural rubber latex and non-latex versions. Who uses it: clinic and hospital staff who stock urology supplies, supply buyers, and students learning device terminology.

What it is

Under 21 CFR 876.5130, a urological catheter is “a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.” Robinson catheters fall under that definition. Distributor listings describe the Robinson pattern as a red rubber catheter with a rounded closed tip and two staggered eyes (Cardinal Health product listing via WellBefore, checked 2026-10-30).

How it is built

Per the same distributor listing, the tubing is red rubber, the tip is closed and rounded, and two staggered drainage eyes sit near the tip. The FDA’s Global Unique Device Identification Database (GUDID) classifies Bard and ConvaTec Robinson products under the term “single-administration urethral drainage catheter” and records them as single use and prescription (Rx) devices (openFDA UDI data, checked 2026-10-30).

FDA classification of Robinson catheters

openFDA lists product code KOD, “Catheter, Urological,” as Class II under 21 CFR 876.5130, reviewed by the Gastroenterology and Urology panel. The regulation sets Class II (performance standards) for the catheter itself; accessories such as a ureteral stylet or connector can fall in Class I and be exempt from 510(k) premarket notification, subject to 21 CFR 876.9.

Types and variants named Robinson

Product (GUDID brand name) Labeler Natural rubber latex label GMDN term
Bard Robinson Catheter; Bardex Urethral Catheter Robinson Model C. R. Bard, Inc. Labeled as containing natural rubber latex Single-administration urethral drainage catheter
Robinson Nelaton Catheter ConvaTec Not labeled as containing natural rubber latex Single-administration urethral drainage catheter
Robinson (catalog description: Silicone Robinson Catheter) Cook Incorporated Not labeled as containing natural rubber latex Ureteral catheter

Source: openFDA device UDI records for brand names containing “Robinson” under product code KOD, checked 2026-10-30. The table shows why the name alone does not tell you the material or the anatomical site: the Cook product is recorded under a ureteral catheter term, while the Bard and ConvaTec products are urethral drainage catheters.

Sizes and specifications that matter

Size (French) Length
8, 10 12 in
12, 14, 16, 18, 20 16 in

Source: Cardinal Health Robinson red rubber urethral catheter listing as shown by the distributor WellBefore, checked 2026-10-30; this is one product line, not a universal standard. GUDID records for Bard list individual catheters such as 10 French x 16 inch and 22 French x 16 inch, so size ranges differ by manufacturer.

Latex labeling

21 CFR 801.437 requires devices that contain natural rubber and contact humans to carry the statement “Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.” The regulation’s purpose is that some people are at risk of severe anaphylactic reactions to natural latex proteins. Because Robinson-named products include both latex-labeled and non-latex-labeled records, check the individual product’s label and instructions for use rather than assuming from the name.

Safe use and handling basics

The FDA records above show Robinson catheters as single-use, prescription devices. Follow the manufacturer’s instructions for use for each package. Insertion technique is clinical training content and is outside this page.

Common mistakes

  • Assuming every Robinson-named product is red rubber or latex. FDA records show non-latex Robinson products.
  • Treating a Robinson catheter as the same product as a Foley. Check the product records for each rather than treating them as interchangeable; see what a Foley catheter is.
  • Comparing sizes across manufacturers without checking each product’s own specification.

FAQ

Is a Robinson catheter a prescription device?

The GUDID records for the Bard, ConvaTec and Cook Robinson products list them as prescription devices (checked 2026-10-30).

Is a Robinson catheter FDA Class I or Class II?

Class II under 21 CFR 876.5130, product code KOD.

Does a Robinson catheter contain latex?

It depends on the product. The Bard Robinson records are labeled as containing natural rubber latex; the ConvaTec and Cook Robinson records are not.

Related pages

See the urinary catheter types and selection guide, the Texas catheter and Malecot catheter explainers, urinary drainage bags and the urology clinic supply checklist. Supplies in this category are listed under urological catheters.

Sources

  • 21 CFR 876.5130, Urological catheter and accessories, https://www.law.cornell.edu/cfr/text/21/876.5130 (checked 2026-10-30)
  • 21 CFR 801.437, User labeling for devices that contain natural rubber, https://www.law.cornell.edu/cfr/text/21/801.437 (checked 2026-10-30)
  • openFDA device classification, product code KOD, https://api.fda.gov/device/classification.json?search=product_code:KOD (checked 2026-10-30)
  • openFDA device UDI (GUDID) records, https://api.fda.gov/device/udi.json?search=brand_name:robinson (checked 2026-10-30)
  • Cardinal Health Robinson red rubber urethral catheter listing, WellBefore, https://wellbefore.com/products/cardinal-health-robinson-red-rubber-urethral-catheter (checked 2026-10-30)

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