Cleared Traditional

K770528 - NEEDLE

K770528 is the FDA 510(k) clearance for NEEDLE by American Viggo. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K770528 · American Viggo · General Hospital
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Apr 1977
Decision
42d
Days
Class 2
Risk

K770528 is an FDA 510(k) clearance for the NEEDLE, MEMBRANE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by American Viggo (Walker, US). The FDA issued a Cleared decision on April 29, 1977 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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 American Viggo devices

Submission Details

510(k) Number K770528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1977
Decision Date April 29, 1977
Days to Decision 42 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 129d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 212
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K770528.
NEONATAL LUMBAR PUNCTURE TRAY
K832556 · American Pharmaseal Div. Ahsc · Sep 1983
INTRADISCAL THERAPY NEEDLE
K831610 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1983
NEEDLE, TRUCARE VACUTAINER
K790086 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1979
FILTER DEVICES
K761098 · Arrow Intl., Inc. · Jan 1977
DOUBLE-ENDED NEEDLE
K760780 · Travenol Laboratories, S.A. · Nov 1976