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FDA product code · Gastroenterology, Urology · Class 2

EZL: Catheter, Retention Type, Balloon

EZL is FDA's product code for "Catheter, Retention Type, Balloon": a Class 2 device classified under 21 CFR 876.5130, reviewed by the Gastroenterology, Urology panel.

510(k) review time for EZL

Across 32 510(k) clearances under EZL decided from 2018-01-01 to 2026-10-06, the median was 169 days from FDA receipt to decision. Half took between 99 and 263 days, and 80% were decided within 265 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, EZL, decisions 2018-01-01 to 2026-10-06 (n = 32)
Fastest25
25th percentile99
Median169
75th percentile263
80th percentile265
90th percentile281
Slowest755
Median days by decision year, EZL (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20181779
20241235

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

EZL in the public FDA record

Records naming EZL, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years130
Device recalls85
Establishment listings269
GUDID device identifiers1,467

Counts of records, not of devices or events. Adverse event reports for EZL are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite EZL

3 FDA recognized consensus standards cite EZL, 1 of them recognized only in part, among them ASTM F623-19; ASTM D1894-14; ISO 20696 First edition 2018-06; Corrected 2019-12. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 9-132 ASTM F623-19 — Standard Performance Specification for Foley Catheter
  • 9-142 ASTM D1894-14 — Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
  • 9-143 ISO 20696 First edition 2018-06; Corrected 2019-12 (partial recognition) — Sterile urethral catheters for single use

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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