Cleared Traditional

K200556 - AquaFlate Pre-Filled Sterile Water Syri...

K200556 is the FDA 510(k) clearance for AquaFlate Pre-Filled Sterile Water Syri... by H R Pharmaceuticals, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K200556 · H R Pharmaceuticals, Inc. · Gastroenterology & Urology device
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Mar 2020
Decision
28d
Days
Class 2
Risk

K200556 is an FDA 510(k) clearance for the AquaFlate Pre-Filled Sterile Water Syringe 10mL. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by H R Pharmaceuticals, Inc. (York, US). The FDA issued a Cleared decision on March 31, 2020 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all H R Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K200556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2020
Decision Date March 31, 2020
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EZL Catheter, Retention Type, Balloon

All 58
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K200556.
Foley Balloon Catheter for Urology
K201776 · Apollon Co., Ltd. · Dec 2020
Prefilled Syringe
K202698 · Hangzhou Primecare Medical Co., Ltd. · Dec 2020
HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
K192034 · Pathway, LLC · Apr 2020
Silicone Foley Catheter
K182463 · Biosensors International Pte, Ltd. · Nov 2019
Urethrotech UCD
K190060 · Urethrotech · Oct 2019
Signal Catheter
K182635 · Safe Medical Design · Jan 2019

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.