Cleared Traditional

K770382 - NEEDLE

K770382 is an FDA 510(k) clearance for NEEDLE, manufactured by Erika, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K770382 · Erika, Inc. · Gastroenterology & Urology device
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Mar 1977
Decision
8d
Days
Class 2
Risk

K770382 is an FDA 510(k) clearance for the NEEDLE, FISTULA, ERIKA. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Erika, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1977 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Erika, Inc. devices

FDA 510(k) Submission Details - K770382

510(k) Number K770382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1977
Decision Date March 08, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 130d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 124
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K770382.
GAMBRO VENOUS BLOOD LINE
K770691 · Gambro, Inc. · Apr 1977
TRANSDUCER PROTECTOR, RT-901, RT-902
K770524 · Renal Systems, Inc. · Mar 1977
PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2
K770475 · Travenol Laboratories, S.A. · Mar 1977
STOPCOCK, ONE WAY
K770383 · Cobe Laboratories, Inc. · Mar 1977
BARIOR
K770213 · Tri-Med, Inc. · Feb 1977
DNC 161 VINCA-FLO
K770043 · Sorensen Research · Jan 1977