Cleared Traditional

K851453 - HOSPAL FISTULA NEEDLE

K851453 is an FDA 510(k) clearance for HOSPAL FISTULA NEEDLE, manufactured by Hospal Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K851453 · Hospal Medical Corp. · Gastroenterology & Urology device
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Apr 1985
Decision
18d
Days
Class 2
Risk

K851453 is an FDA 510(k) clearance for the HOSPAL FISTULA NEEDLE. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Hospal Medical Corp. (East Brunswick, US). The FDA issued a Cleared decision on April 29, 1985 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Hospal Medical Corp. devices

FDA 510(k) Submission Details - K851453

510(k) Number K851453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1985
Decision Date April 29, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 131d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIE Device Classification - Class 2, Special Controls

Product Code FIE Needle, Fistula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 Peers - FIE Needle, Fistula

All 63
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K851453.
JMD AV FISTULA NEEDLE (MODIFICATION)
K860789 · Jms Co., Ltd. · Mar 1986
JMS AV FISTULA NEEDLE
K860241 · Jms Co., Ltd. · Feb 1986
PLUME Y SET
K854951 · Hospal Medical Corp. · Jan 1986
DUAL FLOW NEEDLE
K832136 · Travenol Laboratories, S.A. · Oct 1983
MEDISYSTEMS FISTULA NEEDLE
K811838 · Medisystems Corp. · Sep 1981
GAMBRO A-V FISTULA NEEDLE SET
K802956 · Gambro, Inc. · Dec 1980